• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MedSun: Newsletter #51, August 2010

  • Print
  • Share
  • E-mail
-

Newsletter #51, August 2010

Safety Tips

Air or Electric Dermatome Instruments: Medical Device Safety Tip

Print Item
E–mail Item

FDA Medical Device Safety

FDA has received several reports of patients suffering lacerations when undergoing skin grafting procedures with air- or electric-powered Dermatome surgical instruments made by Zimmer, Inc. Zimmer found that in each case the devices were out of specifications or damaged because they had not been properly maintained.

Additional Information:

FDA Medical Device Safety. Air or Electric Dermatome Instruments. July 21, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm219563.htm

Return to Top

Return to Medsun Home


Articles

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays - Recall

Print Item
E–mail Item

FDA MedWatch Safety Alert

Affected 6PERC or 8PERC Shiley Tracheostomy Tube cuffs may not be able to hold air due to a leak in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal.

Additional Information:

FDA MedWatch Safety Alert. Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays. July 22, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220022.htm

Return to Top

Return to Medsun Home

Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser - Class I Recall

Print Item
E–mail Item

FDA Medical Device Recalls

There is potential for the device to fail to detect air in line at the end of an infusion. Hospira mailed clinical bulletins to affected customers on April 9, 2010, and an updated clinical bulletin on June 11, 2010. In the June 11, 2010 letter, Hospira states the user does not have to remove or stop using the Symbiq infusion pump. Hospira also provided recommended mitigation actions for users.

Additional Information:

FDA Medical Device Recalls. Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser. July 15, 2010.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm219194.htm

Return to Top

Return to Medsun Home

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Print Item
E–mail Item

FDA MedWatch Safety Alert

FDA has received reports of air or gas embolism occurring during or immediately after application of hemostatic drug or biological products using air- or gas-pressurized sprayers. These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site.

Additional Information:

FDA MedWatch Safety Alert. Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism. July 9, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218530.htm

Return to Top

Return to Medsun Home

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc. - Class I Recall

Print Item
E–mail Item

FDA MedWatch Safety Alert

Failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.

Additional Information:

FDA MedWatch Safety Alert. LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure. July 2, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm217980.htm

Return to Top

Return to Medsun Home


LabNet

Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System - Class I Recall

Print Item
E–mail Item

FDA MedWatch Safety Alert

The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods. All Cepheid MRSA/SA Blood Culture Assay products have a potential of generating infrequent rates of false negative MRSA results, which could result in incorrect treatment or delay of care for patients with MRSA infection.

Additional Information:

FDA MedWatch Safety Alert. Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System - Class I Recall. July 2, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218038.htm

Return to Top

Return to Medsun Home

Microtome Safety

Print Item
E–mail Item

Lab Manager Magazine

Because of the associated hazards with microtomes, safety must be incorporated into every step of the process to keep fingers and hands protected. The provided safety tips can help prevent exposure to solvents and biologicals.

Additional Information:

Lab Manager Magazine. Microtome Safety. June 3, 2010.
http://www.labmanager.com/stips.asp?ID=122

Return to Top

Return to Medsun Home

Bilirubin: The Lab's Role in Diagnosis of Neonatal Hyperbilirubinemia

Print Item
E–mail Item

AACC Clinical Laboratory News

The role of the laboratory in the assessment of hyperbilirubinemia is to provide accurate bilirubin results. A number of methods are available on clinical analyzers, some of which need to be improved, as well as transcutaneous devices that are becoming more prevalent. More extensive studies on the correlation between transcutaneous devices and clinical laboratory analyzers need to be completed to determine the acceptability of the transcutaneous measurement within the context of screening for hyperbilirubinemia.

Additional Information:

AACC Clinical Laboratory News. Bilirubin: The Lab's Role in Diagnosis of Neonatal Hyperbilirubinemia. June 2010.
http://www.aacc.org/publications/cln/2010/june/Pages/SeriesArticle.aspx

Return to Top

Return to Medsun Home


HeartNet

Cardiac CT

Print Item
E–mail Item

International Atomic Energy Agency Radiation Protection of Patients (RPOP)

With the current level of knowledge, coronary CTA is not a screening procedure for coronary artery disease. Standard invasive coronary angiography remains the gold standard for evaluation of coronary anatomy. Some position statements on CT coronary artery calcium score screening are available from professional societies. In 2006 a consensus statement of the American College of Cardiology and the American Heart Association recommended against CT calcium scoring in asymptomatic individuals.

Additional Information:

International Atomic Energy Agency Radiation Protection of Patients (RPOP). Cardiac CT. 2010.
http://rpop.iaea.org/RPOP/RPoP/Content/InformationFor/HealthProfessionals/1_Radiology/ComputedTomography/CardiacCT.htm

FDA Radiation-Emitting Products. Computerized Tomography (CT). April 4, 2010.
http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/ucm115317.htm

FDA Radiation-Emitting Products. Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. February 23, 2010.
http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199904.htm

Return to Top

Return to Medsun Home


HomeNet

Featured HomeNet Report of Interest

Print Item
E–mail Item

Your reports of adverse events, and more importantly, reports of 'potential for harm', 'near miss', and 'close call' medical device-related safety concerns are of special interest to FDA and MedSun. HomeNet is particularly interested in learning about problems with medical devices used in the home as a function of the unique use environment, such as:

•Concerns with device instruction for use and labeling
•Issues with patient and caregiver training
•Issues with device appropriateness and compatibility in the home setting

In this featured HomeNet report of interest, the patient was unable to initiate total parenteral nutrition (TPN) infusion on two Cadd infusion pumps manufactured by Smith’s Medical. Shop tests of the pump revealed no defects and the TPN fluid intended for delivery was found to be within the manufacturer's specifications. Home care pharmacy was not aware of any extenuating circumstances that may have existed that would explain why two pumps might have been reported to fail on the same patient. Given these circumstances, the most likely explanation was that the patient had forgotten instructions on how to operate the pump after initially successfully utilizing the pump.

This event is particularly interesting because it provides information about the patient’s ability to understand and comply with instructions for device operation. This report also includes useful information learned by the facility when they tested the device in question and in their communications with other segments of their facility, specifically home care pharmacy.

If you become aware of problems with devices indicated for use in the home or with devices that are typically used in the home setting, with devices that fail or do not perform as intended, or those that represent a potential for harm, please report these events through your MedSun representative, if you are a member of MedSun or HomeNet., or through your hospital’s reporting policy.

If you are not affiliated with a hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related adverse events a model for patient safety.

Please see the MedSun report provided under Additional Information below.

Additional Information:

MedSun Report. March 16, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D76%27%2F8%20%0A

Return to Top

Return to Medsun Home


KidNet

FDA Website Provides Information about Pediatric Medical Devices

Print Item
E–mail Item

FDA Products and Medical Procedures

FDA maintains a pediatric medical device webpage with information on issues associated with medical device use in children. For more information, including current initiatives, guidance documents, device resources and links, visit the link below.

Additional Information:

Pediatric Medical Devices. FDA Products and Medical Procedures. April 30, 2009.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135104.htm

Return to Top

Return to Medsun Home


SightNet

CONSTELLATION Vision System - Recall

Print Item
E–mail Item

FDA MedWatch Safety Alert

Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause eye injuries, including blindness.

Additional Information:

FDA MedWatch Safety Alert. CONSTELLATION Vision System – Recall. July 20, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219665.htm

Return to Top

Return to Medsun Home

The Sun & Your Eyes: What You Need to Know

Print Item
E–mail Item

Healthy Women

The intense ultraviolet (UV) rays of the sun damage sensitive cells in the eyes, eventually affecting vision. Experts say it is difficult to isolate the exact amount of damage that UV radiation imposes on the eye over a long period. However, a number of studies have shown that the effects build up and may increase the chance of developing eye problems later in life. This article provides information on how to reduce the risk of sun damage to the eyes.

Additional Information:

Healthy Women. The Sun & Your Eyes: What You Need to Know. April 2010.

http://www.healthywomen.org/sites/default/files/ffSunEyes.pdf

Return to Top

Return to Medsun Home

Global Perceptions & Vision Care Realities

Print Item
E–mail Item

Global Eye Care

The diversity of perceptions and beliefs around the world presents significant challenges for vision care companies that operate globally. But despite the enormous differences in the countries we surveyed, one message is clear. Adults and children around the world are neglecting primary eye care.This neglect hampers timely and effective correction of childhood amblyopia and refractive error, which can have a significant impact on school performance and delays intervention for serious conditions such as glaucoma, hypertension, and diabetes.

Additional Information:

Global Eye Care. Global Perceptions and Vision Care Realities. March 2010.
http://www.clspectrum.com/article.aspx?article=&loc=archive\2010\march\cls0310_a13.html

Return to Top

Return to Medsun Home


Highlighted MedSun Reports

Highlighted Reports

Print Item
E–mail Item

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period May 1 through May 31 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device 1:
Type: Anesthesia Machine
Manufacturer: Draeger Medical Systems, Inc.
Brand: Apollo
Model: Apollo
Other #: software version 3.21

Device 2:
Type: Anesthesia Recordkeeping System
Manufacturer: Philips Medical Systems North America, Inc.
Brand: Compurecord
Other #: software version F.00

Problem:
An upgrade of our CompuRecord patient charting program from version D.02 to F.00 was necessary to allow operation with BayTech's new model DS3 acquisition unit. (Our existing M4 and M8 models are no longer available.) After the upgrade was completed, users reported that a "Comm Port 1 Fail" error message was occurring periodically on the anesthesia machine. It was determined that on Apollo anesthesia machines using the M4 or M8 units, the "Comm Port 1 Fail" message was displayed briefly at ten second intervals, although the actual patient data acquisition and recording seemed unaffected. For Apollo machines using the DS3 unit, there is no error message, but the acquired patient data in the CompuRecord chart appears for 15 seconds and disappears for 30 seconds, producing periodic gaps in the patient's saved data record.
======================
Health Professional's Impression
======================
Recurring Comm Port Fail alarms are a distraction for the anesthesiologist and may cause genuine alarm messages to be overlooked. Frequent gaps in the patient's data record are not acceptable.
======================
Manufacturer response for Anesthesia Machine, Apollo
======================
Drager tech support affirmed that all source code for their Medibus protocol is provided to vendors. There are two software versions current in Apollo machines; ver 3.21 and ver 4.10. It's possible that CompuRecord software may be qualified to one version and not the other.
======================
Manufacturer response for Patient Charting program, CompuRecord
======================
Initial reply was that CompuRecord periodically polls the comm port looking for information, and that the "Comm Port 1 Fail" message was "normal" for version F.00. There was no comment about repeated 30-sec periods of lost patient data. After additional communication, Philips is investigating compatibility of version F.00 with both Drager software versions and the BayTech DS3 unit.
======================
Manufacturer response for digital acquisition unit, BayTech
======================
Mfr provided information that obsolete models M4 and M8 contained internal digital memory. Newer model DS3 is a digital switch only and contains no internal memory.


Device:
Type: Catheter, Epidural
Manufacturer: Arrow International, Inc. (subsidiary of Teleflex, Inc.)
Brand: Flextip Plus
Lot #: RF 8123601
Other #: 122208 1813

Problem:
Doctor placed CLE (continuous lumbar epidural) catheter without incident. When he attempted to push his medications through the catheter, it was completely occluded. MD tried to troubleshoot but realized it was a catheter malfunction. Catheter had to be removed and patient had to be stuck again due to faulty equipment.
======================
Health Professional's Impression
======================
Doesn't know


Device:
Type: Connector, Airway Access
Manufacturer: Carefusion 211, INC.
Brand: Neo-verso
Cat #: CSC200

Problem:
Nurse called to infant's bedside because he had been desaturating. Patient currently being hand bagged. When we tried to reattach infant to ventilator patient started to desaturate again. Tried to suction patient at this time but unable to pass in-line suction catheter through airway access adapter. Trach tube appeared to be obstructed. The infant returned to baseline after a new trach tube was placed.
======================
Health Professional's Impression
======================
The airway access adapter is really a Y-connector that allows staff to suction the airway without disconnecting the ventilator. Apparently a silicone seal came off the adapter and lodged in the cone-shaped input of the trach tube causing the obstruction.
======================
Manufacturer response for Airway Access Adapter, AirLife
======================
No official comment yet.


Device:
Type: Flowmeter, Tube, Thorpe, Back-pressure Compensated
Manufacturer: Precision Medical
Brand: Select Flowmeter
Model: Ohmeda
Cat #: 3MFA1005

Problem:
Flowmeter had a crack in its base which was not easily visible, but a modest weight (e.g., humidifier) attached was enough to spread the crack and cause leakage. The flowmeter indicated proper flow, but very little of it entered the humidifier to the patient. When the problem was discovered and the flowmeter was replaced, the result was "noticeable improvement" in the patient's O2 saturation.
======================
Health Professional's Impression
======================
Physical damage was already visible on the flowmeter when it was put in use. Most of one hose barb and a 2-cm portion of the base were broken off. Attempted use of the obviously damaged flowmeter led to the problem of the leaking crack and inadequate oxygenation of the patient, which may have been avoided if the flowmeter had been reported and sent for testing after it was damaged.
======================
Manufacturer response for Oxygen flowmeter, Select
======================
Manufacturer was given details and photographs, and did not think it was necessary to have flowmeter sent to them.

See device images:
Image of flowmeter with cracked base.  Resulted in inadequate patient oxygenation.

Image of flowmeter with cracked base. This shows the flowmeter and tubing. Resulted in inadequate patient oxygenation.

Device:
Type: Laryngoscope, Video
Manufacturer: Verathon Medical
Brand: Glidescope Gvl
Model: Ranger

Problem:
Patient presented to ED [Emergency Department] with c/o [complaints of] aphasia and right sided facial droop. Patient examined and believed to be experiencing a stroke. Plan made to transfer patient to higher level of care for specialty treatment for stroke. Patient was requiring intubation. MedEvac [Medical Evacuation] flight team member was attempting to intubate patient using the GlideScope Ranger when the screen became difficult to view. It appeared to lose video feed and had black lines through the screen. The MedEvac staff member adjusted the screen, moved the handle and checked the cord. The MedEvac staff member was unable to duplicate the circumstances initially but then had a sudden clear view moments later. However, the screen then went back to incomplete views and at times had a total black screen. MedEvac staff member stated that he was removing the handle when the screen became viewable again, so intubation was quickly achieved at this time. No further issues with patient. No injury noted. Possible small delay with intubation but no decline in patient's respiratory status during this incident. Patient's transfer was then continued to other facility. Manager of MedEvac was contacted and he took scope to Clinical Engineering for analysis/interrogation.


Device 1:
Type: Tube, Tracheostomy
Manufacturer: Covidien Shiley
Brand: Shiley 4cfs Cuffless
Model#: 582060
Other #: Shiley 4 CFS

Device 2:
Type: Tube, Tracheostomy
Manufacturer: Smiths Medical
Problem:
An order was placed [within the hospital] for a tracheostomy tube size 5. A Shiley size 4 trach [was ordered] based on the manufacturer's guidelines that a Smiths Medical size 5 is the same as a Covidien Shiley size 4. So, when you go to give the clinician a size 5 trach, you have to get a Covidien Shiley size 4. So the size 5 trach for Covidien Shiley will have a 4 on the box since the sizes are not equivalent. It is very confusing for the doctors and respiratory therapists since the sizes are not comparable amongst different vendors. It is a process that is set up for confusion and error.
======================
Health Professional's Impression
======================
The labeling and packaging for the sizes is not consistent amongst Smiths Medical and Covidien Shiley for Tracheostomy Tubes.


Device:
Type: Ventilator
Manufacturer: Covidien Puritan Bennett
Brand: 840
Model#: 840

Problem:
Ventilator failed during operation, went inoperative and alarmed. This problem occurred in 4 different ventilators with a total of 6 BDU replacements. The time between initial purchase and failures is as follows:

Vent 1 11 months
Vent 2 27 months (Subsequent failure: 4 months)
Vent 3 26 months (Subsequent failure: 4 months)
Vent 4 15 months
======================
Manufacturer response for Ventilator, 840
======================
Manufacturer service engineer responded and replaced BDU CPU [breath delivery unit central processing unit]and Exhalation Valve. The manufacturer has provided no communication as to the root cause.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Bio-Med Devices
Brand: Crossvent
Model#: 2i

Problem:
Transport vent turned on for set-up prior to placing patient in isolette. Touch screen control turned on but did not respond to touch and therefore ventilator could not be used for transport. Patient required manually ventilation for transport.
======================
Health Professional's Impression
======================
Touch screen was broken.
======================
Manufacturer response for ventilator, Crossvent 2i
======================
Sent for repair. Touch screen replaced.


CARDIOVASCULAR

Device:
Type: Catheter, Ablation, Cardiac, Ep
Manufacturer: St. Jude Medical
Brand: Therapy Cool Path
Lot #: K21374
Cat #: IBI-83327

Problem:
The catheter tip was bent before it was used. It was an out-of-package failure.


Device:
Type: Catheter, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Lot #: 15082675
Cat #: NI75TCFH

Problem:
After the procedure was underway, the mapping catheter kept jumping around on the screen even though they were not moving the catheter and the patient was not moving either. Unable to acquire mapping points accurately. The ablation catheter was replaced with a new one and problem was resolved. No harm came to this patient.


Device:
Type: Defibrillator, Implantable
Manufacturer: Medtronic, Inc.
Brand: Secura Dr
Model#: D224DRG

Problem:
The patient was admitted via ED three days ago, with the chief complaint: "defibrillator keeps going off." The patient was in rapid atrial fibrillation at that time, "which necessitated multiple ICD charges and shocks in rapid succession. The charge time exceeded the allowance of the device and the end of service indicator was triggered: recommendation is to perform an ICD generator change/replacement since the ICD will not function properly." The ICD was explanted and another ICD implanted. The device was returned to Medtronic for evaluation. The patient's outcome from the EP perspective was satisfactory.
======================
Health Professional's Impression
======================
The physician believes that this was the sentinel event that lead to the Medtronic notice.
======================
Manufacturer response for ICD, SECURA
======================
"...Medtronic will be informing physicians of a rare device software issue in our current ICD and CRT-D devices. The good news is that this issue can be resolved by a software download installed via the programmer. As of April 19th, 2010, Medtronic has 5 confirmed reports out of approximately 144,000 devices worldwide. No patient injuries or deaths have been reported as a result of this issue. Medtronic has identified the root cause to be associated with a rare and specific sequence of events that must occur within milliseconds of each other. Medtronic estimates that the rate of occurrence of this specific sequence of events resulting in excessive charge times in an ambulatory setting to be 1 in 27,000 devices per year (.0000037 per year). We will be responsible for loading the updated software on your programmers and we anticipate the software will be FDA approved in the next few days. Once the software is loaded, upon a patients' next in-clinic interrogation the device will receive the update and their device will be corrected.


Device 1:
Type: Lead, Defibrillation
Manufacturer: Medtronic, Inc.
Brand: Sprint Fidelis
Model#: 6949

Device 2:
Type: Lead, Defibrillation
Manufacturer: Medtronic, Inc.
Brand: Sprint Quattro Secure
Model#: 6935

Problem:
The patient was found to have a fractured Right Ventricular (RV) lead during follow up and underwent RV lead extraction and reimplantation of new lead and azygos coil. The new lead was open but not used. It had to be changed because the lead had problems with the screw-in mechanism. No injury was caused to the patient, however Medtronic would like both leads returned to them for analysis and possible credit to the hospital.


Device 1:
Type: Pacemaker, Implantable
Manufacturer: ELA Sorin
Brand: Reply Dr

Device 2:
Type: Pacemaker, Implantable
Manufacturer: ELA Sorin
Brand: Reply Dr

Problem:
A patient with complete heart block was undergoing placement of a dual-chamber pacemaker implant. After the placement of an ELA ventricular lead in the right ventricular apex and an atrial lead, both leads were connected to the ELA Sorin REPLY device which had exhibited intermittent loss of capture in the V lead. Another device was tried and also failed. A Zephyr St. Jude generator was then connected and functioned successfully. There did not appear to be a problem with the leads since the third pacemaker worked. There was no patient harm.


Device:
Type: Physiological Monitor, Module
Manufacturer: Philips Medical Systems
Brand: Intellivue Mms
Model#: M3001A

Problem:
While monitoring the ECG waveform on the MP90 monitor, for no apparent reason the QRS complex flat lines and the monitor alarms asystole. While alarming asystole the waveform will produce what appears to be a square wave (an overload of input to ECG module) and then back to flat line and some time later corrects itself. During one of the early incidents a nurse had a patient on a drip to slow down the heart rate. When she saw asystole alarm she immediately shut down the drip. As she continued to review data on the monitor she realized the alarm and waveform were incorrect and that the arterial blood pressure (ABP) and central venous pressure (CVP) were correctly displaying good pleth waveforms. No adverse outcome, but the monitor caused a response from the nurse that stopped treatment. This problem has occurred in all three ICU's and at random beds at random times and only one monitor at a time. During investigation there were external devices used; a wireless laptop was in use in the bed next to the affected bed. By turning on and off the laptop we could reproduce the problem. A Blackberry phone in the area would repeatedly cause the monitor to alarm Asystole. In a different ICU 8 floors away a ventilator with heated circuit caused asystole alarm.
======================
Health Professional's Impression
======================
Philips Field Service Engineer queried fellow Field Service Engineers (FSE) and learned our MMS ECG firmware version D.02.02 needed to be upgraded. FSE upgraded all MMS ECG firmware (in MP90 monitors) to D.02.05 and X2 model monitors to release G.01.76. This was done to prevent the possible interference caused by Neptune heaters (humidifiers) in the patient ventilators.

Humidifier research engineers contacted this reporter regarding the incident at this facility and a sister facility. They stated there is an issue with another company's monitors and the Neptune heated circuits and were concerned about Philips Monitors. They informed us that they are in the process of a software upgrade to eliminate potential interference with physiological monitors by raising the frequency used in the heated circuits.
======================
Manufacturer response for Physiological Monitor, Module, INTELLIVUE MMS
======================
Field Service Engineer upgraded all MMS ECG firmware to release D.02.05 in an attempt to reduce or eliminate the ECG
interference they were experiencing. The issue could be replicated by use of a cellular phone and a laptop computer using a wireless card. After the upgrade, no interference was observed.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Gastroscope, Esophageal, Endoscope, Flexible, Rigid
Manufacturer: Olympus
Brand: Gastroscope
Model#: GIF-Q180

Problem:
A gastroscope was not insuflatting properly while in the patient. The scope was removed from the patient and the physician irrigated the biopsy port. At that point a brown substance was expelled. This scope was sent to biomed for the issue of non-insufflation. Biomed could not duplicate the problem and put the scope and cart back into service. The scope has been reprocessed and sent to the manufacturer for a thorough evaluation, repair and replacement.


GENERAL HOSPITAL

Device:
Type: Ambulatory Infusion Pump
Manufacturer: Smiths Medical, Inc.
Brand: Cadd Solis
Model#: 2100

Problem:
Over the past few months, I've begun to see an increase in the number of downstream occlusion alarms. Clinical Engineering has documented several instances in which the occlusion alarm is occurring at 4-5 psi when the initial test value when purchased 14 months ago was near 18 psi.
======================
Health Professional's Impression
======================
I believe that the pressure sensor is drifting out of specification over time. Devices sent to the manufacturer have either had the sensor replaced or calibrated. No repaired device has subsequently failed.

Device:
Type: Catheter, Picc
Manufacturer: VYGON
Brand: Vygon Premicath
Model#: 1261.203
Lot #: 041580
Cat #: 1261.203 28G (1Fr)

Problem:
A premature neonate was born by emergency Cesarean and was admitted to the NICU for management of issues related to his prematurity. The next day the neonate underwent the insertion of a peripherally inserted central catheter (PICC) for long term intravenous access using a Vygon Premicath Model 1261.203 1Fr catheter. The PICC was placed without incident and chest x-rays were done to facilitate and confirm placement. The line was subsequently used to deliver intravenous fluids and total peripheral nutrition without complication.

On day seven, during a routine IV tubing change, the nurse disconnected a connector and discovered that a guidewire was still in place within the PICC catheter. The neonatologist was notified and the guidewire was easily removed. The wire appeared to be fully intact. The length of the wire was compared to a second wire from an unused kit and they were identical in length. A chest ex-ray was obtained after the wire was removed and the PICC line remained in good position. The neonate suffered no harm nor was there a change in treatment plan based on this event. The package insert that indicates that the stylet needs to be removed is labeled with a size 6 font with a gray color on an onionskin paper.
The neonatal intensive care unit had recently switched to this brand of 1 Fr PICC line, which has a guidewire in place within the line to provide extra rigidity for easier advancement. The guidewire is attached through a port that closely resembles an access port for intravenous fluids. There are no identifying markings on this port and the guidewire is not visible. There are no labels or inserts indicating the presence of the guidewire. No previous brands or models of 1 Fr PICC lines used by NICU clinicians had contained guidewires including a similar model - Vygon Premicath 1261.20 -- staff was not accustomed to the presence of the guidewire.


Device:
Type: Catheter, Picc, Stylet
Manufacturer: BARD Access Systems, Inc.
Brand: Groshong Nxt Picc
Lot #: REUC0254

Problem:
Patient presented to outpatient department for PICC dressing change and brought to the nurse's attention that a wire appeared to be inside the PICC tubing. The nurse was also able to visualize this wire. This PICC line was removed and replaced with another PICC, Groshong. An x-ray was taken of the patient's chest following removal of the guidewire which confirmed proper placement with no issues identified. The patient was discharged. The PICC in question was xrayed and it was determined that there were two pieces of the guidewire inside the Groshong. The hospital staff then tested a second PICC (#2) from a new package (lot# REUB1198) by running it gently through the fingers upon which the guidewire fractured just above the magnetic rings. A similar issue was discovered involving a different type of PICC kit, which also included the Sherlock guidewire from a different facility in the organization - lot# RETK0645/Power Picc with Solo catheter. This kit was also returned to the manufacturer for evaluation. All BARD PICC kits in the organization, which included the Sherlock guidewire were pulled from stock and returned to the manufacturer for replacement stock.


Device:
Type: Ecg Data Management Database System
Manufacturer: GE Medical Systems Information Technologies
Brand: Muse
Model: MUSE
Other #: Current software version 7.1.1

Problem:
Patient 12 lead ECG Records found by edit lab staff in the MUSE unconfirmed report listing with inaccurate names assigned to records by automatic process in MUSE.

-Records transmitted to MUSE as PID: 999999999, Name: Absent.
-Records found in unconfirmed report listing as PID: 999999999, Name: lastname, firstname

Issue communicated to Biomed by the hospital's Cardio ECG Lab staff in mid 2008. Biomed later investigated and completed additional testing to confirm the reported issue.

Biomedical / clinical engineering: As hospital medical and information technology interface and share data, the integrity of each system's database becomes increasingly interdependent. It is necessary to develop an understanding of all data processes that occur before, during and following data acquisition and storage in order to verify patient record fidelity. This report details the characterization of improper automated hospital information systems data merges with regard to patient records in a GE Healthcare MUSE clinical database.

Initial discussions with GE: No corrections to the Normalization process would be made in Version 5 - will consider as a feature request for Version 7.

The problem is ongoing. The latest version (7.1.1) does not bring resolution to the issue. GE's response included recommendations for practice change, but did not specifically address the problem reported in any of the new versions (including 7).

GE has decided to make the concern a feature request. GE basically recommended that user always assigns the proper PID and name before transmission to the system. Do not confirm patient records containing default PID. Any combination of alphanumeric characters will be accepted as a valid PID. Determine if there are any existing confirmed records with PID sequences of all 9s or any other default PID as defined by your institution. To set defaults PID settings for your institution create a report for each default PID that contains that PID # and enter "Unknown patient" or similar in patient name field and confirm the report. Any subsequent records with a default PID and no patient name will now have name field populated with Unknown patient. This will alert user to the fact that record needs to be assigned correct patient demographics.

New logic should require a minimum of 2 patient identifiers for any merge to take place. Additional safeguards should be in place at 12 lead carts and bedside monitors that operate as sources of patient diagnostic information. These safeguards should limit the possibility for record export without adequate patient ID information.


Device:
Type: Port, Implanted
Manufacturer: AngioDynamics
Brand: Vortex Mp Port
Ref# MP-P5SAT
Other #: Size = 5 French

Problem:
Patient had a Vortex 5 French LP port placed in right chest on five months ago. The patient finished chemotherapy earlier this year and recently came in on for routine follow-up to the oncology clinic. The patient was complaining of pain around the right upper chest area. A blood draw could not be done from the Vortex port. A chest x-ray was done, which found the catheter broken off from the reservoir, which had migrated deep into the heart. The patient was taken to the cardiac cath lab, and the procedure for removing the catheter via right femoral artery by interventional cardiologist was successful. Subsequently, the reservoir was removed by surgeon. The catheter and reservoir was sent to pathology and a picture was taken (available upon request). The picture shows the catheter tubing is clearly broken off (not disconnected) about 0.5 cm from the reservoir. The patient was observed overnight and discharged home in stable condition.

See device image:

The picture shows the catheter tubing is clearly broken off about 0.5 cm from the reservoir.


Device:
Type: Pump, Infusion, Elastomeric
Manufacturer: Stryker Instruments
Brand: PainPump 2
Model: PainPump 2
Lot #: 10043022

Problem:
Stryker PainPump 2 filled with 400mL of medication, programmed and started. Immediately received "triangle E2" error message. Second pump filled, programmed and started without difficulty. Pump returned to Stryker for analysis.

This is one example in a series of ongoing problems. Over the past several months we have noticed an increase of problems with the Stryker Pain Pump 2 and BlockAid pumps. The problems have occurred with a variety of lot numbers and fall into three main groups:
1. programming issues (e.g. inability to program, or display of error messages when trying to program)
2. battery issues (e.g. pump would not turn on, stopped working, or displayed error message)
3. leaking issues (e.g. leaking at connector site). At least 18 pumps have been affected by these problems.

The events have occurred when the pumps were used for perineural applications, and have been experienced by several different clinicians at two different healthcare facilities. The pumps are all programmed at the hospital, and the problems are identified almost immediately. No patients have been harmed to date, although pain therapy has been delayed. We have been using this pump for several years, and these problems are reminiscent of the previous recall that Stryker issued in November 2008. We have returned all of the recent problematic devices to Stryker for evaluation.


OBSTETRICS/GYNECOLOGY

Device:
Type: Hydrothermablator
Manufacturer: Boston Scientific Corporation
Brand: Hydro Thermablator System (Hta System)
Model#: 56000
Cat #: 56000

Problem:
Patient for laparoscopic bilateral tubal ligation and hydrothermal endometrial ablation. Hydrothermal Ablation machine going through steps for hysteroscopic visualization. Fluid draining from visualization chamber going to collection bag, no fluid return from hysteroscope device. Fluid draining from IV bag supply into collection bag, not going through to the hysteroscope. Surgeon unable to adequately visualize cavity due to inadequate distention. Machine turned off, set-up steps repeated with same results. Sales representative called for troubleshooting; additional disposable devices obtained. Machine set-up with new disposable devices with same result. Laparoscopic procedure performed prior to ablation at this point, waiting for sales rep arrival. All steps repeated in presence of sales rep, who stated it is not turning on like it should, (talking about motor of machine) as computer components with appropriate displays present. Ablation performed using another system. Hydrothermalablator tagged, taken to desk for evaluation/repair. No harm to the patient. Substitute equipment used.


OPHTHALMIC

Device:
Type: Intraocular Lens Testing
Manufacturer: Carl Zeiss
Brand: Iolmaster
Model#: V 4.08

Problem:
IOL Master screening was done pre-op for cataract surgery, R eye reading accurate, L eye reading inaccurate but no alarm or highlight related to the size discrepancy. Cataract size ordered as indicated by test result and on post op day one patient found to have worse vision and it was determined that the wrong size lens was implanted.
======================
Health Professional's Impression
======================
Instead of rejecting a false measurement, the machine used it to incorrectly calculate a wrong lens implant size. This is because when the cataract is too dense, the IOLMaster can not give an accurate measurement. Instead of reporting an erroneous measurement, it should indicate the need for a different test. It may be helpful to allow for calibration of the software if the test is inaccurate. The physician realizes there are human factors involved but feels there could be an improvement to the software/reporting out of results.


ORTHOPEDIC

Device:
Type: Power Screwdriver
Manufacturer: Stryker
Model#: 4200A

Problem:
It was reported that there were two drills in use on the case: a two button model Stryker 4200A with separate buttons for forward and reverse modes, and a single button model that is repositioned to select forward or reverse modes. The MD primarily utilizes the two button drill. When drill was requested to remove the stabilizing screw from the cutting device (using the reverse mode), the scrub tech passed the single button drill and the MD inserted the screwdriver tip in contact with the screwhead and initiated the drill in the forward mode instead of using the reverse mode to back out the screw causing the screw tip (Zimmer part 6290-00-556) to break.
======================
Health Professional's Impression
======================
The MD inserted the screwdriver tip in contact with the screwhead and initiated the drill in the forward mode instead of using the reverse mode to back out the screw.


PHYSICAL MEDICINE

Device:
Type: Bed, Air Fluidized
Manufacturer: KCI USA, Inc
Brand: KinAir Medsurg
Model: KinAir Medsurg

Problem:
The wheels would not lock on a KCI low air loss bed in SICU. When care giver leaned on bed it would move easily. Mattress is such that when the mattress is on max inflate the patient slides easily on the mattress. Combined with the bed moving, both the care giver and the patient are at risk for injury.

Vendor personnel did demonstrate the proper procedure for locking the wheels however, only the wheels at the lower end of the bed lock. The two at the head end do not. Vendor personnel admitted this is true of all of these beds.

Co-workers confirmed they have the same issue in other rooms with similar beds.


Device:
Type: Wheelchair
Manufacturer: GF Health Products
Brand: E&j Traveler Xd

Problem:
Patient had just delivered a child and was being transferred from the labor and delivery room to a patient room. Patient was transferring from the wheelchair to the bed. During the transfer, the cushion which supports the leg on the right footrest was folded up. The patient's right leg caught on the bracket where the cushion attaches to the footrest. The patient sustained a laceration which required 36 sutures to repair. Patient received home health care post discharge.


RADIOLOGY

Device:
Type: MRI
Manufacturer: GE Medical Systems, LLC
Brand: Signa HDX
Model: Signa HDX

Problem:
Pressure plate (rupture disc) located directly above MRI unit had released helium gas into dedicated MRI duct system leading to the roof. The gas escaped out of the appropriate area.
======================
Health Professional's Impression
======================
During checks and analysis, we could not find a reason or cause for the "Quenching of the magnet." These things happen sometimes with reason, sometimes without. This one was one that has no reason that we can ascertain according to our analysis and investigating of the error logs of the system. The system is running well. This seldom happens, but we are continuing to do our daily checks to keep tabs on the system. The rupture disc burst, venting cryogenic helium into the outdoor atmosphere. We are not sure why it burst. There was no patient in the room at the time and, except for some water vapor that developed in the area surrounding the discharge duct (that leads to the rooftop hood), there did not seem to be any discharge into the room. There is a slight sulfur smell in the air that no one can identify. Two Clinical Engineering technicians are looking over the magnet and computer room and assure us that there is no danger present to anyone.


Device:
Type: X-ray System, Cath/angio
Manufacturer: Philips Medical Systems USA, Inc.
Brand: Philips Allura Integris 5000
Model#: Integris 5000

Problem:
In early September 2008, a contracted third party serviced the hospital's Philips Integris 5000 fluoroscopy unit in response to the annual regulatory radiation machine physicist's inspection. Several weeks later, a patient underwent cardiac ablation. The dosimeter report for a physician for this monitoring period indicated a high reading. The Physician stated that the badge was left by the source. Room monitoring badges and other EP staff badges were within the normal range. The subsequent dosimeter monitor report showed another high reading (level II) for the physician. The third party servicer was contacted for on-site service of the unit, and discovered that an internal "low dose" mode had been linked to the "high dose mode" during a prior service visit in mid September 2008 (by a technician working for the third party servicing company). Several months after the patient's ablation procedure, the patient's physician informed the hospital's Imaging Director of patient radiation burns and treatment. Hospital Risk Management has been in contact with the patient / spouse about family concerns.

Comment from FDA: MedSun has received additional reports with this product

Return to Top

Return to Medsun Home


Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Peripherally Inserted Central Catheters

Print Item
E–mail Item

The Peripherally Inserted Central Venous Catheter (PICC) is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tubes, and suture wings for catheter securement that is inserted into a peripheral vein and advanced to the superior vena cava. The PICC is available in single, double, and triple lumen configurations [1]. “The catheter is radiopague and may be provided as a stand alone device or the catheter may be provided in a kit with other legally marketed products”[2].

“The PICC device is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients, the sampling of blood, and for power injection of contrast media” [3]. “The PICC is generally selected for IV therapy that is prescribed for less than 6 to 8 weeks. Although, a PICC may indwell for a shorter period, the average indwelling time for a PICC is 2-6 months. The basilic, cephalic and median cubital veins of the arm are the preferred locations for PICC insertion in adults; scalp veins such as the posterior auricular and temporal veins may be used for neonatal patients. For pediatric patients, the saphenous, popliteal, and femoral veins of the leg may be used, with the tip location in the inferior vena cava” [4].

Over the past year, MedSun has received 46 adverse event reports associated with the PICC device manufactured by the following manufacturers:
• Becton Dickinson
• Bard Access Systems, Inc.
• Cook Medical
• Teleflex Medical
• Medcomp
• Covidien
• Vygon
• Navilyst Medical

These reports were submitted by 34 hospitals between 07/2009 and 07/2010. The most frequently reported device problems were:
• 21 reports associated with catheter breaks
• 9 reports associated with the structural material (hole in material, frayed, knotted, torn,
• 9 reports associated with leakage
• 3 reports with no associated device problem
• 2 reports associated with catheter fractures.
• 1 out-of-box failure (kink in the catheter).
• 1 report of the catheter bursting.

None of these reports resulted in a patient death, although patient injuries (listed below), were reported in 11 of these 46 reports.
• 3 reports of device fragments in the patient
• 2 reports of dyspnea
• 2 reports of erythema, swelling, edema, and, ecchymosis
• 1 report of thrombosis
• 1 report of underdose
• 1 report of embolus
• 1 report of vasopasm

Of the reports that listed patient age, 22 reports had a patient age listed as less than 21 years and 16 reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 15 reports involved female patients and a total of 21 reports involved male patients.

These MedSun reports contributed to FDA awareness of these types of device problems. FDA continues to investigate these problems. If you have experienced problems with the use of PICCs, please report them to the FDA.


Summary of MedSun Reports Describing Adverse Reports between July 2009 and July 2010 with The Peripherally Inserted Central Catheter
Device Device Identifiers Event Description
Becton Dickinson Catalog 384466, Lot #’s 7114730, 9113195, 9063169, 9063769 A 2.6 French dual lumen BD catheter was placed. Eight days later the catheter was noted to have leakage from the blue port at the bifurcation, but then stopped. Two days later at noontime, the blue port again was noted to be leaking at the bifurcation. The infant was also noted to be febrile and had an elevated white count. After extensive team discussion, the decision was made to clamp off the blue port and use as a single lumen. Later on that day at 1600, the red port was noted to be leaking. A decision was made to remove the line. The patient currently has a single lumen broviac used for parental nutrition/intralipids, dopamine, opioid infusion, and has an 8 French left internal jugular hemodialysis catheter. Additional access was required for triple antimicrobial coverage and sedation. After eight attempts, a peripheral IV was placed in the right foot. There have been recent incidences of leaking of BD dual lumen catheters elsewhere in the hospital over the past few months for which a practice alert had been sent. At that time a NICU CNA checked all lot numbers in the unit and confirmed lot numbers were not included in those reported as defective. A decision was made not to remove from stock given that there was no available replacement of appropriate size.
Bard Access Systems, Inc. 5 FR PowerPicc with Sherlock tip location system (TLS) stylet Catalog 9275118, Lot #REUA1183 A female patient was admitted with respiratory and cardiac issues. A PICC (peripherally inserted central line) was inserted and a routine post insertion chest film revealed what appeared to be a 6 cm wire fragment in her axilla vein. The wire fragment is presumed to be from the tip of the stylet wire used to insert the catheter. An interventional radiologist physician removed the wire fragment without difficulty.
Becton Dickinson 2.6 French 20G double Lot# 9113195 A surgically placed 2.6 double lumen BD L-catheter PICC was leaking. The PICC was noted to have small amount of blood on dressing after lab draw 1-2 weeks ago. At the time the RN changed the dressing, flushed the line, and saw no further leaking. Use of the line was resumed. Yesterday after a lab draw, blood again was noted under the dressing near where catheter enters the white bifurcation. The dressing was again changed and line flushed with no visible leaking. Use of line was resumed. The lot number of line is 9113195, which is the same lot # as last leaking line. Labs were drawn and lines flushed only with 10 ml syringes per RN. No sutures are on the line itself only through the wings securing to skin. The plan for this patient was discussed with NICU and surgical attending with the risks and benefits of changing the line discussed. Attempt will be made by NICU team to place new PICC. If unsuccessful, alternative options will be discussed at that time. A meeting is planned for tomorrow with products, IV team, nursing, and surgery to discuss PICC product options moving forward.
Cook Medical, PICC Peripherally inserted CVC set with Nitinol Wire Guide Catalog# G36221; PICS-501-MPIS-NT-ABRM At the beginning of the shift it was reported that the end of patient's inserted PICC had came off along with the green cap. The catheter was still clamped. The team was notified. The pediatric surgeon was consulted and discussed new line placement with patient's mom. The catheter was dressed with chloraprep pads and alcohol, and then secured with foam tape to patient's chest. A new peripheral IV was started to make sure the patient received his antibiotics.
Cook Medical, PICC Peripherally Inserted CVC Set with Nitinol Wire Guide Catalog#G36221; PICS-501-MPIS-NT-ABRM Mom had put the call light on for the nurse to flush the placed PICC because the clamp had come undone. I flushed the line with saline with no problems, and then heplocked it. Patient & Family-Centered Care (PFCC), and charge nurse notified
Bard Access Systems, Inc. Brand name: Groshong NXT PICC Lot # REUC0254 A patient presented to the outpatient department for a PICC dressing change and brought to the nurse's attention that a wire appeared to be inside the PICC tubing. The nurse was also able to visualize this wire. This PICC line was removed and replaced with another PICC, Groshong. An x-ray was taken of the patient's chest following removal of the guide wire which confirmed proper placement with no issues identified. The patient was discharged. The PICC in question was x-rayed and it was determined that there were two pieces of the guide wire inside the Groshong. The hospital staff then tested a second PICC (#2) from a new package (lot# REUB1198) by running it gently through their fingers upon which the guide wire was noted fractured just above the magnetic rings. A similar issue was discovered involving a different type of PICC kit, which also included the Sherlock guide wire from a different facility in the organization (lot# RETK0645) Power PICC with Solo catheter. This kit was also returned to the manufacturer for evaluation. All BARD PICC kits in the organization, which included the Sherlock guide wire were pulled from stock and returned to the manufacturer for replacement stock.
Cook Medical, Brand name PICC Peripherally Inserted CVC Set with Nitinol Wire Guide Catalog# G36221; PICS-501-MPIS-NT-ABRM Centrally placed PICC needed to be flushed because the clamp had come undone.
Vygon, Brand name: LifeCath 1.9Fr PICC unknown Silicone PICC was found broken with blood and fluid leaking out of the device into the bed. The volume of fluid loss was estimated at 1-2 milliters. There was an abrupt interruption of IV nutrition. There was no repair kit available for this device (it was from another hospital). The device was ultimately repaired with another Vygon brand catheter. Break of line = risk of infection. The time to repair was about 30 minutes, which caused an interruption of IV nutrition. The effect on the blood sugar was unknown.
Bard Access Systems Catalog# 0600040, Lot# RETH0401, When checking the patency of the line prior to placement, it was noted to have a hole in it.
Vygon, Brand name: Vygon Premicath Model 1261.203, Catalog 1261.203 28G (1Fr), Lot#041580 A premature neonate was born by emergency Caesarean and was admitted to the NICU for management of issues related to his prematurity. The next day the neonate underwent the insertion of a peripherally inserted central catheter (PICC) for long term intravenous access using a Vygon Premicath Model 1261.203 1Fr catheter. The PICC was placed without incident and chest x-rays were done to facilitate and confirm placement. The line was subsequently used to deliver intravenous fluids and total peripheral nutrition without complication. On day seven, during a routine IV tubing change, the nurse disconnected a connector and discovered that a guide wire was still in place within the PICC catheter. The neonatologist was notified and the guide wire was easily removed. The wire appeared to be fully intact. The length of the wire was compared to a second wire from an unused kit and they were identical in length. A chest ex-ray was obtained after the wire was removed and the PICC line remained in good position. The neonate suffered no harm nor was there a change in treatment plan based on this event. The package insert that indicates that the stylet needs to be removed is labeled with a size 6 font with a gray color on an onion skin paper. The neonatal intensive care unit had recently switched to this brand of 1 Fr PICC line, which has a guide wire in place within the line to provide extra rigidity for easier advancement. The guide wire is attached through a port that closely resembles an access port for intravenous fluids. There are no identifying markings on this port and the guide wire is not visible. There are no labels or inserts indicating the presence of the guide wire. No previous brands or models of 1 Fr PICC lines used by NICU clinicians had contained guide wires including a similar model - Vygon Premicath 1261.20 -- staff were not accustomed to the presence of the guide wire.
Unknown Unknown A broviac central line became occluded. TPA (tissue plasminogen activator) was used times two in an attempt to clear the line. When this was unsuccessful, the line was changed out in the OR and a piece of the catheter sheared off and lodged in the heart. It is unclear what surgical techniques were used as part of the catheter exchange. A cardiac catheter was performed to retrieve the foreign body from the heart. The patient did not have any complications from the catheter. The device may not have contributed to the event. It could have been surgical techniques that were used to remove or exchange the occluded catheter.
Bard Access Systems, Inc. Brand name: PowerPICC Model/Catalog 9275118 Lot#REUA0719 The guide wire fragment was seen on x-ray. A review of the diagnostic film traces the fragment to the line inserted 20 days prior. There was an attempt to retrieve the fragment in interventional radiology, and the retrieved part of the fragment. Additional smaller fragments remain in the pulmonary vasculature and are unable to be retrieved. The removed fragment is in possession of Risk Management at the hospital.
Bard Access Systems, Inc. Brand name: Bard Dual Lumen 12F Hickman Lot# HUTK0519 The device failed and needed to be replaced with another double lumen catheter because there was leakage from the catheter due to several pin holes on each lumen.
Navilyst Medical, Inc. Brand name: Vaxcel Model 46-457 Lot# 1373688 A patient had a PICC line in their right arm. The nurse removed the cap, drew blood, and then connected IV tubing to the PICC line. Vancomycin was infused through the PICC line. At the end of the infusion, the line was flushed with saline. The nurse was unable to disconnect the line, and the tubing broke off with the male connector still in the PICC line. The PICC line was removed and patient had to have a new PICC line placed.
Bard Access Systems, Brand name: Sherlock Catalog#9755305, 9655405, 9857505,9957505 Lot#RESG0681,RETB0533,RETG0274, RESI0937, RETI1043, RETK0881,RESF 0289 Other device# 3 FR Groshong, 4 FR Groshong, 5 FR 45 cm Groshong, 5 FR 55 cm Groshong For approximately fourteen months, it has been noted that in nine patients a "reaction" has occurred after flushing with normal saline following PICC placement. We began using the Sherlock wire in these catheters approximately five months before the first reported adverse event. There seemed to be a vagal/histamine reaction, with signs of tightness in throat, and puffy eyes. With the latest case, the patient had increased coughing associated with redness in face. The patient denies shortness of breath. At first, we thought that it was because of the power flush after the placement. Now, we think it may be the wire.
Bard Access Systems, Brand name: PowerPICC Solo Catalog# REF 91941080, Lot#REUB0619 The Pt had a PowerPICC Solo line placed in the right upper arm (RUA). IV antibiotics were hung and the PICC was flushed and running fine. The next morning, the pt awoke and the RN found the RUA PICC bulb end disconnected from the catheter. It was in the bed beside the pt. There was no back bleeding observed within the lumen of the catheter. The pt was asymptomatic for air embolus and the catheter line portion was removed intact.
Mfr. Unknown, Brand name: Groshong Central Venous Catheter unknown A Pt was sent to the hospital for the removal of a fractured Groshong catheter that was within the right atrium and right ventricle. This admission occurred when the pt's physician (outside of this facility), realized during an attempt to remove the catheter, that the catheter was only partially removed (part had fractured internally).
Becton Dickinson Infusion Therapy Systems, Inc. Unknown During a 26 gauge PICC line dressing change, the PICC catheter broke from the hub. The break occurred approximately 0.5cm past the disc portion of the catheter. It is unknown why the catheter broke.
Bard Access Systems, Inc. Brand name: PowerPICC Solo Catheter Catalog# REF 9295108 Lot#REUB0167 During a PICC insertion, there was an equipment failure. The healthcare professional was unable to thread the introducer over the guide wire. It had a defect that was not visible, but a rough area could be felt on the wire. A larger introducer was opened and threaded over the wire without incident. There was no patient harm.
Bard Access Systems, Inc. Brand name: Bard PowerPICC Catalog# REF 9295108, lot#REUB0167 During a PICC placement a hub was attached to the PICC. There was no blood return and the PICC was difficult to flush. The PICC was pulled back and still there was no blood return with flush. The patient's basilic vein vasospasmed and resistance was met. The patient started coughing and the PICC was removed. Noted: magnetic tip sticking out from PICC tip. The wire was pulled from the hub end to make flush with the cut PICC portion, but it did not retract. Pulled entire wire from PICC and magnetic tip stayed in place at cut end of PICC. Pulled magnetic tip out and there was approximately 3-4 cm of wire that had been broken from other portion of wire.
Covidien, Brand name: Argyle Catalog# 43303 A neonatal PICC was placed in an infant. The pigtail was noted to be leaking approximately 1 cm from where the pigtail joins the luer connector. The catheter was removed after several unsuccessful attempts to replace it. The infant was taken to the operating room for surgical placement of a central venous catheter. Of note, this is the 13th similar occurrence of leaking in the same area of the 1.9 French catheter over an 18 month period of time. During the process to determine if the leaking was a practice or product related issue, we examined our practices related to PICC insertion, care, and use. We could not find any common threads. As a result, we provided the rep with 3 (of the 13) catheters to be examined microscopically for clues to any product inconsistencies or reasons identified for the leakage. In the meantime, we have removed the product from our storeroom and substituted a product from another manufacturer. We don't know, but given that we examined our own practices for the possibility of user error, it is possible that there is a device quality control issue.
Bard Access Systems, Inc. Brand name: Power PICC Catalog# 9275118, Lot#RETL0614, Other#91906 A PICC line was placed without incident. A linear hyperdensity of an unknown etiology was observed on chest x-ray. A PICC guide wire fragment was removed. We do not know how this event happened. There is concern of a potential manufacturer defect.
Bard Access Systems, Inc. Brand name: Power PICC Solo Catheter Catalog# 9194118, Lot# RETI 1012 During the procedure to insert a single lumen PICC catheter, the healthcare professional had difficulty advancing the catheter into the vein. A decision was made to change the catheter over wire to a dual lumen catheter. The Sherlock guide wire was removed from the catheter with the tip appearing intact. The catheter was trimmed to 10 cm and a hardwire was inserted into the catheter. The old catheter was removed over the wire and 5cm of Sherlock guide wire were found next to the hard wire. The practitioner proceeded to pull both wires out at once and stopped the procedure. There was a fracture of the Sherlock wire that was about 5cm from the end of the wire.
Bard Access Systems, Inc. Brand name: Groshong CV Catheter Catalog#7726954 This replacement catheter was being flushed at the time by the nurse when one of the lumens of the double lumen catheter broke off. It remains in the patient.
Bard Access Systems, Inc. Brand name: PowerPICC Catalog# 3175108, Lot#RETG0980 The RN was inserting a PICC in patient's right arm. The guide wire frayed and was lodged in the patient's arm. The RN was unable to remove at bedside.
BD Medical Systems, Brand name: BD First PICC Lot#8231654 A night nurse completed a heel stick on the infant and noted edema on the infant's chest area. Upon further review edema noted on bilateral chest area to abdomen with ecchymosed area on upper center of chest just left of midline. PICC infusion stopped at this time and PICC line removed. Approximately two hours later, the dayshift RN measured dark red/purple area on chest at 3.5cm by 2cm in an oblong shape across upper left chest with redness noted radiating out from demarcated line of purple area to under chin and to sternum. Edema noted across chest extending to mid-maxillary line bilateral and down beyond sternal border on right side to lower abdominal quadrant. The entire area soft, and appears non-tender when palpated.
Teleflex Medical Catalog#55064, Lot#RF9086053 The practitioner was called in the morning regarding a "defective PICC" by a nurse in the ICU. The patient had a 5Fr two lumen power injectable PICC inserted. The nurse stated that yesterday she noticed the "port" was separated from the catheter. When investigated, it was found that the pink hub was missing from the catheter. The catheter was clamped right below the missing portion. Tegaderm had also been wrapped around the catheter. The nurse was advised that the catheter would have to be replaced and to notify the MD.
Bard Access Systems, Inc. Brand name: Per-Q-Cath Catalog# 4133110, Lot#REFH0040 A male presented to the emergency department with ulcers to the right foot a week prior to the reported event. During a dressing change, he pulled the skin off the right great toe and it "started spurting blood and pus." He was a known diabetic under treatment for insulin dependent diabetes mellitus, hypertension, hyperlipidemia, coronary artery disease, attention deficit hyperactivity disorder, obsessive-compulsive disorder, and back pain. He was admitted to the medical surgical floor with a diagnosis of diabetic right foot infection with an infected ulcer over the first MP Joint and uncontrolled diabetes mellitus. He received IV antibiotics, warm soaks to the right foot, and dressing changes. Two days later, he was taken to OR for excision debridement of the right foot, right big toe and opening of the metacarpophalangeal joint. As long-term antibiotics were planned for osteomyletis, the physician ordered a PICC inserted by nursing. Two days after the OR procedure, the PICC line was inserted by a seasoned RN with certification in PICC insertion and 13 years experience in this procedure. On the third attempt, the line was placed in the left antecubital basilic. The entire catheter of 19.5 inches was inserted with 0 inches on the outside. Three days after insertion, the PICC line was removed per order by the same RN who inserted the line. After warm soaks were applied to the arm, the PICC line was removed with minimal traction. The tip appeared to be angle cut (as was cut on insertion), but the line only measured 18 inches. At that time, the nurse was curious and tested the line's strength. She "pulled minimally on it and it snapped very easily." In her 13 years of experience, she has never seen a line so fragile. The surgeon on call was notified and a portable chest x-ray was ordered. The x-ray confirmed that part of the catheter remained in the vein, "a 6.2 cm linear density was noted on the more medial aspect of the distal arm just proximal to the elbow consistent with residual PICC line." The surgeon on-call expressed confidence to the RN that no migration should occur as the catheter is in a superficial vessel at the elbow region. A plan was made for the surgeon to remove the PICC residual foreign body two days later and at that time to insert a Mediport. The Mediport was inserted as planned without difficulty, but after venotomy and further fluoroscopy from the elbow to the subclavian, the surgeon was unable to locate the foreign body. A plan was made for x-ray the next day for location of the foreign body. A chest x-ray done the next day revealed a 4.3 cm fragment of the PICC line overlying the right chest in the pulmonary artery. Fluoroscopy and x-rays of the right arm on the same day showed no radiopaque foreign body. Plans were made for transfer to a tertiary facility for removal of the broken PICC line in the right pulmonary artery. Throughout the hospital stay, patient has maintained good blood flow to the arm and free of respiratory symptoms.
Becton Dickinson, Brand name: L-Cath Model 1.9 Fr. A PICC line was inserted one day prior to the event and was infusing well. While doing a routine IV check, the catheter was noted to have snapped off at the hub.
Becton Dickinson Infusion Therapy Systems Catalog#384467, Lot#7170231 A PICC line was discovered to be leaking at the junction where the tubing from the blue port meets the white molded wingset. Attempts to insert the same type PICC line were unsuccessful, and a femoral line was inserted instead.
Medcomp, Brand name: Vascu-PICC Model 3 Fr. Lot# MAVY910 A 3 French Vascu-PICC catheter luer hub cracked during a cap change procedure. The patient had been receiving daily cap changes with blood draws. The PICC was initially placed 12 days prior to the event. The patient had to undergo a repeat invasive procedure and procedural sedation to exchange the cracked catheter for a new catheter.
Becton Dickinson, Brand name: BD First PICC Model 384232 The morning of the anticipated discharge, the patient's right saphenous PICC line (placed in the NICU by an IV RN 23 days prior to the event) was discovered to be fractured at the level of the hub. The line was visualized intact during morning rounds by the surgical team, but a short while later was discovered fractured when the patient's nurse undressed the patient for a diaper change. The internalized 20 cm fragment, proximal to the hub, migrated to her heart. This was confirmed by CXR projecting over the right atrium and right ventricle with one end within a left lower lobe pulmonary artery branch.
Bard Access Systems, Inc. Lot# RETI 0011/TD> The nurse was unable to thread the guide wire of a triple lumen catheter beyond 2-3 cm for PICC placement. The nurse was unable to remove the guide wire as well. A small incision was made to remove the guide wire. A knot was noted at the tip of the guide wire.
Bard Access Systems, Inc. Brand name: Per-Q-Cath Unknown A registered nurse went to remove a patient's PICC line (located on the patient's right upper extremity, removed one stitch and part of the PICC fell out. Twenty-five cm of the PICC line was retained by the patient. STAT x-rays were ordered and the PICC fragment was observed. The fragment was removed by Interventional Radiology. The patient is stable, with plans to be discharged back to the nursing home at the end of the week. The PICC was installed at the nursing home five days prior to the event
Bard Access Systems, Inc. Brand name: Groshong PICC insertion kit Catalog# 7617408, Lot# RETD0235 A nurse was opening a Groshong insertion pack and noticed a kink in the Groshong catheter. The nurse decided to use another Groshong catheter and there was no patient adverse event because the kink in the catheter was discovered prior to use.
Teleflex Medical Model/Catalog# PK-01452-W, Lot#RF8032592 Shearing of the plastic covering was noted at the insertion site involving the guide wire, making it unusable. A new kit was opened and a new site for insertion was selected. There were no further complications to the patient.
Bard Access Systems, Inc Lot# RESK0183 When flushing a dual lumen PICC with a 100cc pre-filled syringe utilizing a push-pause technique, the PICC line burst.
Cook Medical, Brand name: Spectrum Turbo-Ject Lot #’s 786511; 786845; 2268093; 2272821 The Spectrum Tubor-Ject PICC line was being trialed in the Infusion Therapy department. The catheter was going to be used for IV access for chemotherapy administration, antibiotic therapy and blood collection/draws. Thirty-six (36) catheters were placed in various types of patients. Twenty-two (22) of the thirty-six (36) patients experienced some kind of side effect that included a malposition of the catheter, clotting of the catheter and/or phlebitis. Five (5) patients developed a deep vein thrombosis requiring anticoagulation therapy. It was decided to discontinue the use of the catheter. It is thought that the tubing is too stiff possibly causing it to clot and malposition.
Bard Access Systems, Inc. Brand name: Solo PowerPICC Unknown The RN called the patient’s home to schedule an appointment with the patient and her husband said that the (single lumen) PICC IV line cap “cracked off” 2 days prior to the RN’s call. Our on- call RN had to bring a cap out to replace the one that cracked off. The on-call triage RN had the on-call RN go out to do a visit and replace the cap. The patient was receiving supplies while at the Ambulatory Infusion Clinic. With the PICC cap off that protects the patient; there is an increased risk for infection, air embolism, bleeding, etc. This was a "near miss" with what could have happened due to leaving an open line into the bloodstream uncovered. It leaves the patient seriously vulnerable to many potential problems that could even cause death. Since the patient receives her antibiotics at the Ambulatory Infusion Clinic, they usually do not get extra supplies for the home and the patient/patient caregiver are not routinely taught how to troubleshoot their PICC line care and maintenance. At the time of the cap change, the patient was afebrile and was receiving IV antibiotics through the PICC for left lower extremity deep vein thrombosis (DVT). Although the patient later developed septic arthritis three weeks after the cap change and received an additional course of antibiotics, the PICC was successfully discontinued about a week later without signs and symptoms of infection with orders for routine blood cultures x2 for three weeks.
Bard Access Systems, Inc. Brand name: DL Power Catalog# 3275108, Lot#RESI0865 Patient for PICC insertion was poked with echogenic needle. The guide wire would not thread through the needle which required a second stick with a different needle. After the procedure was completed and the needle was inspected, it appears that it was a bur on the guide wire that caused the problem.
Becton Dickinson Infusion Therapy Systems Catalog# 384224, Lot# 9125087 PICC line found in bed, which was broken at the hub.
Becton Dickinson Infusion Therapy Systems Catalog# 384224, Lot# 9125087 PICC line which was broken at the hub was found in the bed.
Becton Dickinson Infusion Therapies, Inc. Brand name: L-Catheter Catalog# 384539, Lot# 9029732 During a dressing check, the RN noted that the PICC line was leaking at the insertion site. The PICC line was in only 24 hours. The PICC line was removed and replaced.
Becton Dickinson Infusion Therapies, Inc. Brand name: L-Catheter Catalog# 384539, Lot#8241714 Upon dressing change, the RN noted leaking of the catheter under the lavender strain relief. The PICC line was removed.
Becton Dickinson Infusion Therapies, Inc. Brand name: L-Catheter Catalog# 384539, Lot# 8275035 Upon removal of a PICC line from a patient, the RN noted a 4.0 centimeter hole from the tip of the catheter.
Becton Dickinson Infusion Therapies, Inc. Brand name: L-Catheter Catalog# 384539, Lot# 8302104 Upon dressing change, the nurse noted leaking at the PICC line. The PICC line was discontinued.

Additional Information:

1. US FDA 510(k) Summary. June 30, 2010. Online Accessible:

http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091586.pdf

2. US FDA 510(k) Summary. June 30, 2010. Online Accessible:

http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091261.pdf

3. US FDA 510(k) Summary. June 30, 2010. Online Accessible:

http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081690.pdf

4. US FDA 510(k) Summary. June 30, 2010. Online Accessible:

http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051194.pdf

Return to Top

Return to Medsun Home

Updated August 1, 2010

Return to MedSun: Medical Product Safety Network

-
-