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

MedSun: Newsletter #74, July 2012

  • Print
  • Share
  • E-mail
-

Newsletter #74, July 2012

Articles

Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen

Print Item
E–mail Item

FDA MedWatch Safety Alert

Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death. Affected products include serial numbers from 042-10000 through 102-09335. These oxygen concentrators were manufactured from January 1, 2004 to May 15, 2010.

Additional Information:

FDA MedWatch Safety Alert. Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen. June 21, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm309426.htm

Return to Top

Return to Medsun Home

Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

Print Item
E–mail Item

FDA MedWatch Safety Alert

Expanded Class I Recall-Serial numbers range from 700000 through 794213. All pumps serviced by SIGMA after September 21, 2010, or remediated as part of the initial recall notification, and all pumps manufactured after November 1, 2010, are not affected by this expanded recall. These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

Additional Information:

FDA MedWatch Safety Alert. Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion. June 15, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.htm

Return to Top

Return to Medsun Home

MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall - Potential for Reverse Flow of Fluid

Print Item
E–mail Item

FDA MedWatch Safety Alert

This malfunction could reverse the flow of fluid or medicines backwards from what was intended. This may cause blood loss, an under-delivery of prescribed medicines or fluids, or a potential delay in therapy. Use of the affected administration sets may cause serious adverse health consequences, including death.

Additional Information:

FDA MedWatch Safety Alert. MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall - Potential for Reverse Flow of Fluid. June 1, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm306327.htm

Return to Top

Return to Medsun Home

FDA Safety Communication: Catheter Entrapment with the ev3 Onyx Liquid Embolic System

Print Item
E–mail Item

FDA MedWatch Safety Alert

The FDA is informing physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes stuck in the implanted Onyx material. The clinical data submitted by the manufacturer prior to marketing included cases where the delivery catheter was difficult to remove, but in all cases the catheter was removed without any adverse patient events. The original product labeling did not reflect the risks related to catheter entrapment but new labeling will include these risks as well as recommendations to help minimize that risk.

Additional Information:

FDA MedWatch Safety Alert. FDA Safety Communication: Catheter Entrapment with the ev3 Onyx Liquid Embolic System. June 29, 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310121.htm

Return to Top

Return to Medsun Home

FDA Safety Communication: UPDATE on Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection

Print Item
E–mail Item

FDA Safety Communication

This update is to notify the public of a recall of additional lots of this product. The FDA continues to advise health care providers STOP using products from lot 120111 because FDA testing revealed that this lot also was contaminated with Pseudomonas aeruginosa and Klebsiella oxytoca bacteria.

Additional Information:

FDA Safety Communication. UPDATE on Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection. June 8, 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm299409.htm

Return to Top

Return to Medsun Home

Webinar - Practical Advice for Preventing Surgical Fires: Safety Strategies from the Front Lines: Materials Now Available

Print Item
E–mail Item

FDA Safe Use Initiative

On June 12th, FDA provided a free educational webinar about Surgical Fire safety titled, "Practical Advice for Preventing Surgical Fires: Safety Strategies from the Front Lines." During this program, we learned about three hospitals' experiences with surgical fires and the prevention strategies they initiated. The FDA Preventing Surgical Fires Initiative website has been updated with webinar materials, such as slides and transcripts. We encourage you to use and further distribute these materials to anyone who may be interested.

Additional Information:

Webinar: Practical Advice for Preventing Surgical Fires: Safety Strategies from the Front Lines. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/ucm301411.htm

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm

Resources and Tools for Preventing Surgical Fires. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/ucm272680.htm

The Preventing Surgical Fires Initiative announces a Free Educational Webinar. MedSun Website. May 2012.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=72#1

Return to Top

Return to Medsun Home

Children and Asthma: The Goal Is Control

Print Item
E–mail Item

FDA Consumer Update

FDA is working to make sure that the drugs and devices used to treat asthma - a chronic lung disease that inflames and narrows the airways - are safe and effective. Uncontrolled asthma can lead to chronic lung disease and a poor quality of life, and may slow growth. This article provides tips on knowing what triggers asthma as well as different treatment options.

Additional Information:

FDA Consumer Update. Children and Asthma: The Goal is Control. June 11, 2012.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm306476.htm

Return to Top

Return to Medsun Home

New FDA Website: Patient Lifts

Print Item
E–mail Item

FDA Website: General Hospital Devices and Supplies

Patient lifts provide many benefits, including reduced risk of injury to patients and caregivers when properly used. However, improper use of patient lifts can pose significant public health risks. Visit the FDA Patient Lifts website for many best practices that can help reduce these risks and enhance the benefits to patients and caregivers who routinely use patient lifts.

Additional Information:

FDA Website: General Hospital Devices and Supplies. Patient Lifts. June 27, 2012.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/ucm308622.htm

Return to Top

Return to Medsun Home


Discussions with Healthcare Providers

Non-Powered and Powered Patient Lifts: MedSun Small Sample Survey Summary

Print Item
E–mail Item

MedSun Website

FDA queried hospital staff, part of the MedSun hospital network to learn about clinician experiences surrounding patient lift use. Survey respondents shared their perspectives about how they are used for daily activities, for safe patient transfers as well as common issues that clinical staff faces. An executive summary of survey results are available online, see additional information below.

Additional Information:

Non-Powered and Powered Patient Lifts: MedSun Small Sample Survey Summary. MedSun Website. June 2012.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=73#5

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 April 1 through April 30, 2012. 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: GE Healthcare
Brand: Aestiva

Device 2:
Type: Software, Patient Data Management
Manufacturer: Picis, Inc.
Brand: Picis

Problem:
One morning of January 2012 anesthesia machines in 7 rooms would reset with a "Watchdog Timeout Failure" alert on ventilator monitors periodically after start of cases. Daily machine checks were performed as usually on machines prior to the start of 0730 cases without problem. It was quickly determined that by removing serial connection from anesthesia machines to computers running PICIS Anesthesia Manager, watchdog error's messages stopped. After further analysis of situation, it was discovered that the PICIS system administrator performed an upgrade to PICIS workstations and did not install drivers in the proper location within PICIS application. Machine checks were successful because a PICIS patient record was not pulled up during machine verification. There were approximately 3 resets to each machine in about 2 minute intervals before problem was identified. Patients were bagged and monitored during temporary machine outages and did not suffer any adverse consequences.
======================
Manufacturer response for Anesthesia Machine, Anesthesia Machine (per site reporter)
======================
Watchdog Timeout error is consistent with a machine communications problem.


CARDIOVASCULAR

Device:
Type: Catheter, Ablation, Cardiac, Cryoablation
Manufacturer: MEDTRONIC CRYOCATH LP
Brand: Arctic Front
Model#: 2AF282
Lot #: 11674
Cat #: 2AF282

Problem:
Upon 2nd or 3rd application we received an error code indicating insufficient pressure. We did some troubleshooting and were advised by the rep to replace the catheter. We opened another catheter and had no further problems. No harm to patient. Will contact the company for return and credit for this catheter. No other follow up is required. No harm to patient.


Device:
Type: External Defibrillator
Manufacturer: Physio-Contol, Inc.
Brand: Lifepak 12
Model#: LifePak12

Problem:
Following code blue with defibrillation x2, RN printed code summary from LifePak 12 monitor memory, but only one shock of 300J printed on the strip.
No need to notify manufacturer. Hospital Bio-med dept checked the equipment, found no deficiencies and determined that the issue was caused by user error. Additional staff training was done.


Device 1:
Type: Introducer, Catheter
Manufacturer: Cook Medical
Brand: Check-flo Performer
Lot #: 2808171
Cat #: G08432
Other #: RCFP-4.0-21-

Device 2:
Type: Introducer, Catheter
Manufacturer: Cook Medical
Brand: Check-flo Performer
Lot #: 2828133
Cat #: G08432
Other #: RCFP-4.0-21-J

Problem:
Prior to insertion, a Cook 4F Sheath Product # G08432 was flushed and prepared for insertion. A 4F left arterial access was obtained. A short time later it was noticed that blood was leaking from the hub of the sheath. The 4F Cook sheath was exchanged for a new 4F Cook sheath. Approximately 40cc of blood was lost prior to the sheath exchange. The patient was noted to have a systolic blood pressure in the 50's. The patient responded well to a 50cc bolus of packed red blood cells given by anesthesia. When the sheath was removed from the patient and flushed, the physician noticed a leak from the hub of the sheath. There were two sheaths used for access, one in the left femoral artery (LFA) and one in the right internal jugular, so packaging from both sheaths was obtained. There was no way of knowing which sheath came from which package each package had a different lot number.


Device:
Type: Introducer, Catheter, Steerable, Cardiac
Manufacturer: St. Jude Medical
Brand: Agilis Nxt
Model#: 408309
Lot #: 3576561
Cat #: 408309

Problem:
The handle used to deflect/steer the sheath stopped working while in the patient's body. No harm to patient. The sheath was removed and exchanged for a new one.


Device:
Type: Lead, Pacemaker, Mri
Manufacturer: Medtronic, Inc.
Brand: Capsurefix Novus Mri
Model#: 5086-45

Problem:
The patient was undergoing a pacemaker and lead implant procedure. Within minutes of the implant procedure the patient experienced a known atrial perforation requiring emergency surgery to repair. A pigtail catheter was used for the pericardiocentesis. The patient coded, CPR was initiated and went to emergency surgery. The patient was discharged to home a week later. This experienced EP physician is very concerned about this lead having encountered 3 perforations within weeks. After decades of experience, these events involving the CapSureFix Novus MRI lead represent his first atrial perforations.


Device:

Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Carescape
Model#: B650-01
Cat #: 2009010-811

Problem:
The GE Medical patient monitor, model: B650 can fail to send a print request to the CIC (GE Central Station) if more than one print command is sent at a time. This will result in a loss of required arrhythmia waveform and patient vital signs documentation.
======================
Manufacturer response for Monitor, Physiological, Carescape (per site reporter)
======================
The Project Manager/Clinical Engineer notified GE Medical of the printer issue. GE Field Services dispatched technical support to the hospital to investigate the reported complaint. They were able to reproduce the problem on site and it is a confirmed problem with this GE Medical monitoring device. GE Medical and the hospital have since replaced the six (6) B650 Patient monitors with the GE Medical Solar 8000i monitor in the Emergency Department. These monitors are working correctly and printing to the CIC (GE central station). There are no other GE B650 patient monitors in use at the hospital at this time.


Device 1:
Type: Monitor, Physiological, Central System
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M3155

Device 2:
Type: Recorder, Physiological, Central
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M3176C


Problem:
The central station monitors (5) suddenly turned off for 8 minutes. According to the monitor technician the blue screen pop-up stated demoing physical memory and counted to 99 then rebooted itself. After 8 minutes the central station monitors turned back on. This was an unknown and unscheduled reboot. No further incidents after that. Two central station recorders have been replaced which are under warranty and there were no similar incidents after replacement of recorders. It is believed that during a replacement of the uninterruptable power supply (UPS) for the central station system one or both of the central recorders caused or contributed to a corruption of the printer driver in the server which contributed to this system reboot.


EAR, NOSE & THROAT

Device:
Type: Instrument, Ent
Manufacturer: Acclarent
Brand: Solo Pro
Lot #: 110603A-CM
Cat #: BC0716SP

Problem:
During the sinuplasty portion of surgery, two successful passes with a 7x16 sinus balloon were completed. On the third pass of the balloon, the balloon failed to inflate. The balloon was removed from the patient. At the back table, the scrub tech tried to inflate the balloon. Sterile water leaked out from the balloon area and the balloon did not inflate. The balloon was then handed off to RN/Circulator in the room. A new 7x16 sinus balloon was opened and used to complete the case. There was no injury to the patient or to the staff involved in the case. The surgeon does not know why this occurred. All staff involved in the case is experienced in using this type of equipment. The surgeon did not encounter any difficulty or change in the way that the equipment was being used between the first, second, or third pass. Staff reports that they have had no other difficulties with this type of equipment.

See device images:

Image of 7x16 Sinus Balloon Catheter product label

Image of Sinus Balloon Catheter equipment.  Balloon is affixed to the catheter and is deflated



GENERAL & PLASTIC SURGERY

Device:
Type: Cable, Monopolar, Electrosurgical
Manufacturer: Gyrus ACMI Inc.
Model#: A0335.1
Cat #: A0335.1


Problem:
While using cautery, team noticed a spark, smoke and a pop when the cautery cord broke off at the end of the cord next to the machine (ESU). Cautery settings: coag 30 and cut 1.
======================
Manufacturer response for Cable, Electrosurgical (per site reporter)
======================
Hospital left phone message with manufacturer to call reporter. We would like to know the life expectancy of the cords.

Device:
Type: Forceps, Curved, Electrosurgical
Manufacturer: Gyrus ACMI L.P.
Brand: Pks Seal Open Forceps
Model#: 915000PK
Lot #: 394761MD
Cat #: 915000PK

Problem:
RN plugged in disposable PK forceps hand piece cable and machine (electrosurgical unit, ESU) did not acknowledge the device. Hand piece switched out with another and the second worked appropriately.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical Inc
Brand: Da Vinci STip Cover Accessory
Lot #: C11350
Cat #: 400180
Other #: Version 10

Problem:
During case, monopolar scissors with cautery for the Davinci, caused arc during procedure. MD stated that the arc had happened and then noticed a hole in the protective sheath that is placed on the scissors. MD noted there was damage to the right external
iliac artery. The scissors were removed, and the protective sheath was replaced before surgery continued.


Device:
Type: Laser Fiber, Endovenous Laser Treatment
Manufacturer: AngioDynamics, Inc.
Brand: Venacure Evlt Nevertouch Frs
Model#: unk

Problem:
The patient has had bilateral endovenous laser ablation combined with microphlebectomy. The patient had recurrent varicose veins form in both lower extremities. Patient now with recanalization of the great saphenous vein bilaterally and mainly proximally. The patient now presents for bilateral repeat endovenous laser ablation of both great saphenous veins combined with microphlebectomy.

Left leg: The great saphenous vein was entered at mid-thigh level and a wire was easily introduced and verified in good position. The cath sheath was then positioned about 1.5cm from the saphenofemoral junction... The laser was turned on and 10 watts used on the left side (total 141.69 seconds/1195.832 joules). Upon removing the catheter from the thigh, it was noted that the gold-tipped laser fiber had fractured and broken off and remained near the exit site of the skin/thigh. After the procedure was completed on the right size, fluoroscopy was used to remove the fractured gold-tipped laser fiber with successful retrieval of the fractured piece. The patient tolerated the procedure without complication and was taken to the recovery room in satisfactory condition. The tip was returned to the manufacturer for an evaluation.


Device:
Type: Laser Fiber, Surgical
Manufacturer: Boston Scientific - Marlborough
Brand: Flexiva
Lot #: ML00000451


Problem:
Surgeon had a flexible ureteroscope in the patient's left ureter. He was using the Holmium laser with a Flexiva 200 fiber wire at settings 0.6/8. Doctor used this fiber wire for a few minutes and then removed it from the ureteroscope. Surgeon asked for a fiber stripper, which tech did not have available. Tech then opened a new Flexiva 200 fiber wire. When surgeon re-entered the flexible ureteroscope, he realized a piece of the previous fiber was laying in the patient's left ureter with some injury to the wall of the ureter. Surgeon then decided to place a ureteral stent and leave the ureteral stone in place at that time. Because of the injury to the ureter and patient's urethral dilatation from this, surgeon did leave an 18-French Foley catheter in and left patient on antibiotics, pain medicine, and Ditropan for 4 to 5 days; and left the stent in for 4 to 6 weeks and will then plan to perform re-ureteroscopy.


GENERAL HOSPITAL

Device:
Type: Heat Seal Sterilization Pouch
Manufacturer: Cardinal Health
Brand: Heat Seal Sterilization Pouch
Lot #: 101009A-SH

Problem:
For the past month the department has been having difficulty with the pouch tear on the Heat Seal Sterilization Pouch. It rips rather than tears. They are all from the same lot. Trying to determine if there is a problem with the product or staff handling. The ripping instead of peeling contaminates the instrument so it is unable to be used and must be reprocessed.
======================
Manufacturer response for Heat Seal Sterilization Pouch, Heat Seal Sterilization Pouch (per site reporter)
======================
Stated they have had no other complaints. Suggested they come in to retrain staff on opening of package.


Device:
Type: Stopcock, I. V. Set
Manufacturer: Vygon, Inc.
Brand: 62" Ultra-microbore Stopcock Set
Lot #: 1008002
Other #: Product code AMS-546-2

Lollipop IconProblem:
Premature infant with PICC cultured Staphylococcus epidermis (Staph epi). The stopcock set packages examined and appear to have stain contamination.
======================
Manufacturer response for Stopcock set, 62" Ultra-microbore stopcock set (per site reporter)
======================
Manufacturer picked up all stop-cock sets of this lot# and replaced.


Device:
Type: Stopcock, Iv Set
Manufacturer: Vygon, Inc.
Brand: 62" Ultra-microbore Stopcock Set
Lot #: 1008003
Other #: Product Code AMS-546-2

Lollipop IconProblem:
Premature infant with PICC cultured positive for Staphylococcus epidermidis (staph epi).
======================
Manufacturer response for Stopcock set, 62" Ultra-microbore stopcock set (per site reporter)
======================
Manufacturer took all of same lot# and replaced with new lot#.


NEUROLOGY

Device:

Type: Catheter, Lumbar Drainage
Manufacturer: Medtronic Neurosurgery
Brand: Edm Lumbar Catheter
Lot #: 11816167

Problem:
The patient had a lumbar drain inserted in the a.m. and arrived to the critical care unit from the post anesthesia care unit. The drain was found by the ICU nurse to be leaking. A crack was found in the transducer section of the drain. The output was minimal. The nurse replaced the lumbar drain tubing and monitored tubing and site remained intact and adequate drainage until the drain was discontinued/removed on post-operative day 7.


Device:
Type: Shunt, Central Nervous System, Adjustable
Manufacturer: Medtronic Neurosurgery
Brand: Strata Nsc
Other #: Strata NSC Lumboperitoneal Adjustable Pressure Shunt

Problem:
Neurosurgery staff has noticed a problem with adjustable shunt valves and the iPad 2. "The iPad 2 (not the case with iPad 1 although there is now a new version and I don't know its characteristics) has a strong magnet on one edge where you can attach the cover. Because some of the valves we use are adjustable with the use of a strong magnet, when the iPad 2 gets within a few inches of the valve, it can change its setting which can pose a risk to our hydrocepahlus patients. While there is no formal study available, we have seen it happen and have tested it with some of our valves. Using the iPad 2 at a normal distance should not cause a problem."


Device:
Type: Surgical Drill, Pneumatic, Hose
Manufacturer: Stryker Instruments, Instruments Division
Brand: Maestro
Model#: 5400-200
Lot #: 1124434883

Problem:
While using the Maestro drill to perform a parietal craniotomy for a cranial hemorrhage, the pneumatic drill hose ruptured explosively with a deafening bang - stunning the lead surgeon. The surgeon had a minor injury to his arm and feels that his hearing may also be affected. Patient did not sustain injury.


ORTHOPEDIC

Device 1:
Type: Pack, Total Joint
Manufacturer: Medline Inductries, Inc.
Model#: CMPJ26848G
Other #: ESU pencil # PSHBTN W/HLST

Device 2:
Type: Radiopaque Bone Cement
Manufacturer: Heraeus Medical
Brand: Palacos
Model#: PALACOS R
Lot #: 72804270
Cat #: 00-1112-140-01
Other #: J014001112140011Y and 1611772804270D11Y7

Device 3:
Type: Electrosurgical Unit
Manufacturer: Covidien, Formerly Valleylab, A Division of Tyco Healthcare
Brand: Force Fx
Model#: Force FX-C

Problem:
After total knee procedure, Physician Assistant (PA) was scraping excess bone cement from knee joint before it dried with electrosurgical (RSU) pencil, which was still plugged into the ESU) PA inadvertently pushed a button on ESU pencil energizing the tip and igniting residual cement that remained on tip outside of surgical site. Ignited blob of cement was thrown to the floor from pencil tip and extinguished with a splash of saline solution. PA temperately came in contact with hot cement which left a 3.5" x 1.75" hole abdomen height, right side of surgical gown. Patient and PA did not suffer injury during event.


Device 1:
Type: Screw, Multi Axial
Manufacturer: Medtronic
Brand: Medtronic Cd Horizon Legacy Spinal System Multi Axial Screw
Cat #: 75646535

Device 2:
Type: Set Screw
Manufacturer: Medtronic
Brand: Medtronic Cd Horizonlegacy Spinal System Set Screw
Cat #: 7560020

Device 3:
Type: Set Screw
Manufacturer: Medtronic
Brand: Medtronic Cd Horizon legacy Spinal System Set Screw
Cat #: 7560020

Device 4:
Type: Spinal, Pedical Fixation
Manufacturer: Medtronic
Brand: Medtronic Cd Horizon Legacy Spinal System Multi Axial Screw
Cat #: 75646535

Problem:
A female patient with congenital scoliosis underwent posterior spine fusion with segmental instrumentation from T5 to L3 with Legacy Medtronic stainless steel instrumentation of 5.5mm. Initial postoperative course was benign.

Four months later the patient suffered an awkward fall and felt immediate pain at the lower right side of her previous surgical reconstruction. The patient was taken to the OR where the surgeon discovered that the lowest right side pedicle screw and set screw had become disengaged. The previously placed screw was removed, a new pedicle screw was placed, the rod was reseated, and a new set screw was placed. The surgeon added a cross-link device as well.
The patient returned approximately one month later with increased lower back pain over the prior week and was again taken to the OR. The surgeon noted that the inferior-most set screw had become loose. The screw and set screw was examined and he found no obvious cross threading or stripping of the screw. The surgeon checked all connections around this one and identified no problems. The surgeon replaced the set screw and carefully tightened it, going to the normal tightening point of breaking off the stem of the set screw, and then went beyond that and further tightened the screw. He attempted to stress the system as much as possible and felt that it was secure.


PHYSICAL MEDICINE

Device:
Type: Infant Heel Warmer
Manufacturer: Covidien
Model#: MH0002T/MH00002N
Lot #: 43154

Lollipop IconProblem:
Infant recently diagnosed with jaundice was seen at an outpatient lab to get a blood draw; using a heel warmer before doing a heel stick. The heel warmer was dropped and the contents sprayed all over the sleeping baby. The patient was cleaned off, but the eyes were not irrigated at that time. Seen in the ER and both eyes flushed with 500 cc of normal saline after consult with Poison Control Center. Evaluated by Ophthalmology due to concerns of corneal chemical exposure from heel warmer solution, sodium acetate. Findings were: 1. Chemical Exposure OU-slight erythema, swelling, skin flaking OU. No evidence of chemical conjunctivitis; pH within normal limits, and no abrasion.


RADIOLOGY

Device:
Type: System, Ultrasound, Diagnostic
Manufacturer: GE Healthcare
Brand: Logiq E9
Model#: Logiq E9
Other #: CN40703

Problem:
Machine freezes while doing an internal transvaginal ultrasound making patient feel uncomfortable. Have to restart machine and wait while probe is inserted in patient and patient is in a gynecologic position which is difficult for some patients to maintain.

Case manager actively working with GE and Biomedical Engineering to rectify the problem. GE ordered several new parts to be installed.


Device:
Type: X-ray System, Cath/angio
Manufacturer: Philips Medical Systems, Inc.
Brand: Alura Xper Fd20
Model#: Alura Xper FD20

Problem:
The Philips FD20 X-ray equipment was displaying a warning that stated the disc was almost full. The staff thought that this meant that studies on the temporary disc would start deleting off, and it was just informing them of this. What this really meant was that the disc was almost full and they needed to delete images to gain space. Unknown to them there were studies that were "stuck", they had been archived over to the Xcelera but had locked and not auto deleted from the FD20. The staff disregarded the message and during a coronary stent procedure the equipment stopped acquiring images because there was no space left. This left the physician with only the capability to fluoro images. Philips was called and could not instruct the team over the phone what to do. I was called and came in and deleted images. By then the case was over. This warning should have given an indication that acquisitions will stop if not addressed. Physician was angry because he said the warning had been there all week. The staff was frustrated because they didn't understand the warning. The patient was not harmed or injured but the proper imaging for documentation was not achieved.

We called the manufacturer on the day of the procedure and they couldn't help the team fix the problem. Subsequently, the engineer called me and we discussed the problem. He was very helpful and explained what the warning meant.


Device:
Type: X-ray System, Cath/angio
Manufacturer: Philips Medical Systems
Brand: Allura Xper Fd20

Problem:
Patient was having cardiac catheterization. During the procedure he became hypoxic and a Code Blue was called. About the same time, the cardiac cath table and X-ray ceased to function. It was discovered that the UPS may have malfunctioned, causing the main breaker to the cath lab equipment to trip. The UPS had to be bypassed in order for the equipment in the room to function. The patient expired but it was felt this was not because of the power failure, but because of his underlying cardiac condition. During the procedure, the patient became hemodynamically unstable including hypotension, bradycardia and hypoxia. The cardiologist could not take an injection picture of the coronary tree because the X-ray machine broke down and there was no other room available. CPR was continued for 40 minutes with no ability to revive the patient.


Device:
Type: X-ray System, Portable, C-arm
Manufacturer: GE OEC Medical Systems, Inc.
Brand: Ge Oec
Model#: REF#400104671321
Other #: REF# 400104671321

Problem:
Patient had left ankle hardware removal surgery today around 8 a.m.. After case was finished, tech took C-arm to tech area to send image to PACS. Dr. wanted only image #2 sent to PACS (only 2 images saved during case - both images were saved about 10 minutes apart from each other). Image #2 (smaller image) could be seen in the image directory, but once small image was highlighted on machine, C-arm would not bring the large image up on left side of monitor. The C-arm would only recognize image #2 as image #1. Example: Image #1=Image #1... but Image #2=Image #1
As a result, image #2 was lost, so left ankle order was cancelled in Mysis (EMR). Doctor was notified by staffperson that image was lost and he said he would order X-rays in the recovery room for the record. Also, staffperson called in machine to our imaging service provider.


Device:
Type: X-ray System, Portable, C-arm
Manufacturer: GE OEC Medical Systems
Brand: Ge Oec
Other #: ref# 400104672038

Problem:
Patient had right hip/femur surgery today around 1300. After case was finished, tech took C-arm to tech area to send images to PACS. One of the 4-5 images that Dr. wanted saved and sent to PACS was not recognized by the C-arm. (Similar to what occurred in another case from this morning). Example: Image #37= Image#37... but Image#38= Image #35. In result, the actual image for #38 was lost. There was a similar image that tech sent instead, so doctor was not notified as study images were complete. Our X-ray service provider was notified.


Device:
Type: X-ray System, Portable, C-arm
Manufacturer: GE OEC Medical Systems, Inc.
Brand: Ge Oec
Other #: CE# 176195

Problem:
Patient had surgery for left lower extremity Taylor Spatial Frame application. Because of the issues with the other (upgraded) C-arms, we researched this C-arm for possible issues. There were discrepancies for this patient... Example for the exam: Image #1 = Image #1... but Image #3 = Image #1. Also on this patient, Image #8 = Image #8 but Image #9 = Image #8. Image #3 and #9 are lost - not able to print and not able to be sent to PACS. This did not result in an incomplete study in PACS. There were other images available that were sent to PACS to complete the study.


Device:
Type: X-ray System, Portable, C-arm
Manufacturer: GE OEC Medical Systems, Inc.
Brand: Ge Oec
Other #: CE# 175500

Problem:
Patient had "percutaneous left nephrostomy with laser lithotripsy, possible left stent placement" surgery today. Tech put this C-arm on 'auto-save' and 'auto-swap' before case started (before any images saved to machine). At some point, after several images were saved during case, Dr. wanted image #1 to be moved/ "saved" to the right screen. When tech tried to bring up image #1 (By 'high-lighting' image #1 in the image directory on the right monitor), the C-arm would recognize image. When tech selected image #1 under the image directory, image #8 actually appeared on left screen of monitor. Image #1 acted like image #8 and image #1 was lost (unable to be pulled up on left screen and unable to be printed). Dr. was very upset with this as it was his "scout image" and he wanted to refer to this image (have it on right screen and compare it to left screen image). When asked if there were any other images he could refer to and he said "No, I needed THAT image."


Device:
Type: X-ray System, Radiographic, Portable
Manufacturer: Shimadzu Medical Systems
Model#: 5037000027

Problem:
Radiology Technologists were present in patient's room for bilateral knee X-rays. Nurse was holding the patient's knee for the X-ray and the collimator light exploded on the patient. Equipment has been pulled off unit. The light is used to assist with positioning and to adjust size of the X-ray field. There would be no increase in radiation exposure to the patient as a results of the collimator bulb bursting.

We purchased our Shimadzu portable X-ray machines from a dealer. The dealer sent a service tech to check the machine and try to determine the reason for the bursting of the collimator bulb. All of his tests indicated that the machine is operating within manufacturer's specifications. The dealer's technician asked for, and we gave them, the remaining pieces of the bulb that we had collected. The dealer and Shimadzu want to analyze them. As a precaution, the technician changed the collimator bulbs on our five other machines that are of the same vintage as the machine in question.

~~~~
Lollipop Icon Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

Return to Top

Return to Medsun Home

Updated July 1, 2012

Return to MedSun: Medical Product Safety Network

-
-