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

MedSun: Newsletter #69, February 2012

  • Print
  • Share
  • E-mail
-

Newsletter #69, February 2012

Articles

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Print Item
E–mail Item

FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

Additional Information:

FDA MedWatch Safety Alert. Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient. January 12, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287575.htm

Return to Top

Return to Medsun Home

CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure

Print Item
E–mail Item

FDA MedWatch Safety Alert

FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 by the manufacturer. FDA continues to work with the manufacturer and other federal agencies to better characterize the problems that led to excessive radiation exposure to patients at certain clinical sites, and is working with the manufacturer to revise the CardioGen-82 labeling to better describe how to use the generator.

Additional Information:

FDA Drug Safety Communication. CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure. January 12, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm263157.htm

Return to Top

Return to Medsun Home

Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue - Update

Print Item
E–mail Item

Workshops and Conferences

The December 2011 MedSun Newsletter provided information about The Food and Drug Administration's (FDA) public workshop entitled: "Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue." The purpose of the public workshop was to receive public comment on the use of scientific research data, including published scientific literature, to extrapolate effectiveness claims from adults to children and between pediatric subpopulations in order to support and establish pediatric indications for medical devices. To view the newly available workshop transcript please see the link below.

Additional Information:

Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue - Update. January 5, 2012.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm278053.htm

MedSun Newsletter. Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue. December 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=67#1

Return to Top

Return to Medsun Home

Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

Print Item
E–mail Item

FDA MedWatch Safety Alert

Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low blood pressure (hypotension), slower than normal heart rate (bradycardia), cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

Additional Information:

FDA MedWatch Safety Alert. Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings. January 4, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm285803.htm

Return to Top

Return to Medsun Home

Urogynecologic Surgical Mesh Implants - Update

Print Item
E–mail Item

FDA Medical Device Safety

Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III. The FDA also continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through a variety of methods.

Additional Information:

FDA Medical Device Safety. Urogynecologic Surgical Mesh Implants – Update. January 4, 2012.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

Return to Top

Return to Medsun Home

FDA Targets Risks From Reused Medical Devices

Print Item
E–mail Item

FDA Consumer Update

Some medical devices are reused many times in common surgical and diagnostic procedures, and have been for years. They include instruments used in surgery (like clamps and forceps), and endoscopes (like bronchoscopes and colonoscopes) used to visualize areas inside the body. And the Food and Drug Administration (FDA) wants to ensure that they are safely reused. Please see the new website with information about these medical tools.

Additional Information:

FDA Consumer Update. FDA Targets Risks From Reused Medical Devices. December 28, 2011.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284636.htm

FDA Device Advice. Reprocessing of Reuasble Medical Devices.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/default.htm

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 November 1 through November 30, 2011. 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:
Type: ET Tube Holder
Manufacturer: NeoTech Products, Inc
Brand: NeoBar
Cat #: N715F
Lollipop Icon


Problem:
We have had previous issues with NeoBar, which was entered to FDA. Since that report, we have had 2 more events in which the hard component of the NeoBar had come detached from the adhesive on the infant's cheek. The alarm had gone off indicating that the infant's oxygenation level was decreasing (desaturating). The NeoBar was replaced without extubating the infant. In both cases, there was no harm to the patient; however, the risk of potential harm is great.
======================
Manufacturer response for ET Tube Holder, NeoBar (per site reporter)
======================
They previously sent NICU [Neonatal Intensive Care Unit] a "Clinical Complaint Questionnaire."


Device 1:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda Inc
Brand: Engstrom Carestation
Model#: Engstrom Carestation
Other #: 400529262

Device 2:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529275

Device 3:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529272

Device 4:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529264

Device 5:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529278

Problem:
The power cord that goes from the wall to the base of the ventilator keeps sliding out of the plug and does not conduct power to the unit. When power is not being conducted to the ventilator, it will not charge the internal battery. If this should happen while on a patient, then there is not a special alarm to signal that it is on battery back up and has the potential to shut down.


CARDIOVASCULAR

Device:
Type: Catheter, Intracardiac Mapping, High-density Array
Manufacturer: Boston Scientific
Brand: Constellation
Lot #: 14374434
Cat #: US8060U

Problem:
Constellation catheter broke inside of the patient. Multi-polar mapping catheter; one of 8 spines of the catheter appears frayed and damaged after it was removed from the patient during the procedure.


Device:
Type: Electrode, Electrodcardiograph, Neonatal
Manufacturer: MedLine Industries, Inc.
Brand: 1. 5Mm Radiotranslucent
Model#: MDS61115R
Lot #: 110521
Lollipop Icon


Problem:
A patient in the ICU was "coding". The leads did not pick up the heart rhythm. The nurse had to hold the green lead against the baby's skin to pick up a tracing. The nurses tried a lead from the same lot number on another patient and they slipped off. The patient was not diaphoretic or clammy, etc. The skin was not prepped and the leads were on less than 6 hours.


Device:
Type: External Defibrillator
Manufacturer: Physio-Control, Inc.
Brand: LifePak 20
Model#: LifePak 20

Problem:
During the daily clinical performance check on the LP20 defibrillator the clinician noted that the defibrillator would not exit the automated external defibrillator (AED) mode when the door was opened. The defibrillator is designed to operate in the manual mode when the control panel access door is opened. Several attempts were made to switch to manual mode by re-opening the door. The defibrillator was removed from service and sent to Biomed for repair.
======================
Manufacturer response for External Defibrillator, LifePak 20 (per site reporter)
======================
Manufacturer provided product complaint number. Biomedical informed field service engineer that defibrillator would be returned to factory for analysis.


Device:
Type: External, Defibrillator
Manufacturer: Physio-Control, Inc.
Brand: LifePak 20
Model#: LifePak 20
Cat #: 3202487-000

Problem:
Our facility has 36 LifePak 20 defibrillators. Over the last few months we have had 6 units with a defective Power Module printed circuit board that enables the battery to be charged. When the unit is unplugged to be used, the battery fails. The unit failed during the routine daily check.


Device:
Type: Filter, Intravascular, Cardiovascular
Manufacturer: Cook Medical
Brand: Cook-celect-venacava-filter Jugular Approach
Model#: IGTCFS-65-1-JUG-Celect
Cat #: IGTCFS-65-1-JUG-Celect

Problem:
The MD went to deploy the inferior vena cava (IVC) filter but when he tried to deploy it, the device would not release per the manufacturers instructions. The device was removed and a new IVC filter was inserted with successful deployment. The device was sent to the manufacturer for evaluation.


Device:
Type: Transducer, Blood Pressure, Extravascular
Manufacturer: Smiths Medical
Brand: Transtar
Model#: MX20984

Problem:
Patient was admitted at around 1700. RN came on night shift and had to change out the normal saline +0.5 units of heparin flush that was running through the arterial line at 3 ml per hour and the CVP (central venous pressure) line which was started at around 2200. So the patient should have been getting a total of 6 ml per hour between the 2 lines. RN changed it out at around 2300 and had to change it again 3 hours later. It was then that the RN realized that something was wrong with the system. The patient had gotten 1L of fluid and 500 units of heparin. RN had the tech change out the entire arterial line/CVP system to remedy the problem. Further investigation revealed that the arterial line transducer was leaking a large amount of fluid, much faster than the CVP or than would be expected. If this had been a 10 kilo baby the outcome could have been much different.

The transducer was sent to clinical engineering for testing, and the following results were found:

Tested both transducers, the first was the Red labeled transducer. Flow rate should be 3ml/Hr. Tested and found flow rate to be 291 ml/Hr. Tested the Blue transducer. Flow rate should be 3ml/Hr and the flow tested to be 4.5mL/hr. The same pressure bag that was used with these transducers was used in testing. The bag was inflated to the black line in the green zone. The results indicate there is a manufacturing defect in the red transducer which is the one that infused too quickly.

The manufacturer's quality control department will be following up with the reporter.


GENERAL & PLASTIC SURGERY

Device 1:
Type: Accessory, Robotic Surgical, Bifurcated Light Cable Guide
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 951021
Other #: also s/n's sf1045105, sf1049030

Device 2:
Type: Drape, Surgical
Manufacturer: Intuitive Surgical, Inc.
Brand: Drape

Problem:
Procedure: Prostatectomy, radical, with robotic assistance.
During placement of the da Vinci instrumentation, one of the bifurcated light guide cables became loose. This was discovered, but not before six small burns occurred in the first layer of the blue drapes. There was no smoke or flame observed. There were cloth towels placed beneath the drape and a towel prevented the patient's skin (face/chest) from being burned. There was no injury to the patient or staff. The MD was notified and the procedure continued.

Device thought to be ignition source: bifurcated light guide cable. Device thought to be the fuel source: da Vinci drape. The patient was intubated (endotracheal tube) and receiving oxygen via a ventilator.

It is believed by surgery staff that this occurrence resulted from human error. The light cable connections were not double checked to assure that they were secure. One person set up the procedure and another person came in and did the case.

Surgery leadership was asked to review information regarding the "Preventing Surgical Fires" initiative on the FDA website online available at: http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm


Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery Inc.
Brand: Ligaclip
Model#: ER320
Lot #: H43Z6W
Cat #: ER320

Problem:
Patient undergoing laparoscopic cholecystectomy. The surgeon encountered a "mis-firing" incident with a 10mm endoscopic rotating clip applier (ER320). The ligaclip applier spit out two clips at once. The surgeon was able to retrieve the second clip, but did not feel comfortable with the continuous use of this device, so opted to sequester it and obtain a new device of same make/model. The case was continued and finished with no further issues. There was no injury to the patient. The device is available for evaluation purposes.


Device:
Type: Clip Applier
Manufacturer: Stryker Sustainability Solutions
Brand: Ethicon
Model#: MCM30
Lot #: 857188
Cat #: MCM30
Other #: size med/long

Problem:
Prior to procedure the surgical technician attempted to load cartridge in reprocessed device. The cartridge would not load into device. The device was immediately removed from field and replaced with new device, which was also reprocessed and worked appropriately. There was no injury to the patient as the device never reached the surgical field. This was caught before use.


Device 1:
Type: Clip Applier
Manufacturer: Covidien
Brand: Covidien
Lot #: P1H0351
Other #: REF 134046

Device 2:
Type: Clip Applier
Manufacturer: Covidien
Brand: Covidien
Lot #: P1G0465
Other #: REF 134046

Device 3:
Type: Clip Appliers
Manufacturer: Covidien
Lot #: P1H0351
Other #: REF 134046

Problem:
The hospital has recently switched over to Covidien supplied vascular clip appliers 9.0mm width. Today, with use of this device, there was a white residue that was discharged from the tip of the clip applier into a sterile neck wound. On closer examination the entire tip of the clip applier was covered in a white residue with intermittent areas of exposed steel. I tried this off the field with nursing staff and we saw gross residue come out. Given that this constituted a foreign body I immediately stopped use of this device. We opened two more devices with the same problem. I discussed with rep who said that this is "Teflon coating". I responded that I have used clip appliers for a long time and have never seen this. Unless Covidien is willing to take responsibility for a Teflon related infection we should remove this product from our shelves.


Device:
Type: Gauze, Sponge
Manufacturer: Covidien
Brand: Tendersorb
Model#: 9194A
Lot #: 110001344862
Cat #: 9194A

Problem:
Wound Care RN reports opening up a Kendall Tendersorb Wet Pruf abdominal pad (8x10 inch in size) and noted there was a large insect trapped between the padding and the netting. Obviously, this occurred during manufacturing. The pad was saved for evaluation purposes. The pad was not applied to the patient. RN caught prior to procedure.


Device:
Type: Instrument, Ultrasonic Surgical, Curved Shears
Manufacturer: Stryker Sustainability Solutions
Brand: Ethicon Harmonic Ace
Model#: ACE 36E
Lot #: 1595151

Problem:
When disposable harmonic handpiece device was about to be used, the harmonic machine kept giving the error message "tissue in jaws". Device jaws were inspected, no tissue found and jaws were wiped off. Device used again only to have the same error message appear, and still no tissue was found in jaws. A new disposable harmonic handpiece had to be opened to use for the remainder of procedure.


GENERAL HOSPITAL

Device:
Type: Catheter, PICC
Manufacturer: Medcomp
Brand: 1. 9Fr X50 Cm Single Lumen PICC
Lot #: MBGA440
Cat #: MR17011

Problem:
PICC line had a crack in the tubing right below the connection with the white hub. This catheter was inserted prior to the receipt and implementation of the new 1.9 F PICC lines with the redesigned hub.
======================
Manufacturer response for 1.9 Fr x 50 cm Single Lumen PICC, 1.9 Fr x50 cm Single Lumen PICC (per site reporter)
======================
No response. Awaiting delivery of newly designed PICC lines.


Device:
Type: Catheter, Umbilical Artery
Manufacturer: Covidien
Brand: Kendall Argyle Polyurethane Umbilical Catheter With Luer Lock Hub
Lot #: 031607
Cat #: 8888 160333
Other #: 0.15ml 3.5 Fr/Ch(1.1mm) x 15 in.(38cm)
Lollipop Icon

Problem:
An umbilical venous catheter and an umbilical artery catheter were placed for monitoring and support in a newborn with respiratory distress. It was noted three hours after placement that the umbilical artery catheter was leaking from just under the Luer connection. The catheter was removed.


Device:
Type: Closed IV Catheter System
Manufacturer: Becton, Dickinson and Company
Brand: Nexiva
Cat #: 383537
Other #: 20 G

Problem:
IV was started in ER, pt went to CT scan. After contrast for CT was injected, tech noted that IV catheter tubing was bulging and reported to ER nurse upon pt return to ER.

Defective catheter removed, replaced with another IV heplock. This is the first report we have of the bulging in the tubing after use in CT scan.

See device images:

Image shows catheter against a blue background.  Catheter has traces of contrast inside clear tubing.  Tubing bulge is evident closest to the needle.

Close up image showing catheter against a blue background. Catheter has traces of contrast inside clear tubing. Tubing bulge is clearly seen - this image zooms in on it.


Device:
Type: Indicator, Biological Sterilization Process
Manufacturer: Advanced Sterilization Products (ASP)
Brand: Sterrad Cyclesure Biological Indicator
Lot #: 264117

Problem:
The product is an ampule with a small amount of bacteria and a medium in a vial, packaged in a tyvek pouch and placed in the sterilizer with other items as a test. The sterilant (Hydrogen Peroxide) is supposed to penetrate the ampule and kill the bacteria. After the sterilizer cycle is complete, we "crack" the vial of medium and mix it with the bacteria. It is incubated and it the sterilizer works, nothing will grow.
The sterilization cycle was complete. The employee was emptying the sterilizer and when she picked up the tyvek pouch which is not very visible, the vial had broken and the contents leaked on her hands. The employee complained of white discoloration and a burning sensation on her hands.
======================
Manufacturer response for Sterrad Cyclesure Biological Indicator (per site reporter)
======================
They requested additional information and recommended gloves be worn. In hindsight, the instructions state "use of gloves as peroxide burns can occur".


Device:
Type: Port, Catheter, Implanted
Manufacturer: Bard Access Systems, Inc

Lollipop Icon


Problem:
Patient has severe hemophilia and receives factor infusions at home. Patient's mother accesses the port and administers product. Recently, the patient's mother accessed his port and had difficulty infusing the product. The home health company was called. The RN came to the home and had difficulty with the port flushing after it was re-accessed. A dye study was performed which showed that the needle had pierced the posterior side of the port. The current port will need to be surgically removed and a new port inserted. Patient will require increased factor and hospitalization following a new port placement.


Device:
Type: Software, Health Information Technology
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Invision Clinicals LCR Medication Management
Model#: INVISION Clinicals
Other #: Software version v.27.3 (and above)

Problem:
The medication dosage form value was not synchronized between the First DataBank (FDB) data, the Common Vocabulary Engine (CVE), the INVISION Service Master, and the relevant INVISION profiles. This resulted in dosing clarifying information, such as CR (controlled release), ER (extended release) and Enteric Coated being omitted from the printed prescription.


Device:
Type: Warmer, Infant Radiant
Manufacturer: Drager Medical Systems
Brand: Babytherm
Model#: 8004

Lollipop Icon


Problem:
Radiant warmer canopy would not move from the center position, or would only move a short distance one direction due to failed swivel joint. The same thing has occurred on four units for the same model and age within the last year. The swivel joint failed, but the canopy remained securely attached and otherwise functional. Four serial numbers of failed units are included in this report. Two were found during routine inspections, and two others were discovered and reported by users.


PHYSICAL MEDICINE

Device:
Type: Pack, Hot Or Cold, Disposable
Manufacturer: HOSPITAL MARKETING SERVICES CO., INC.
Brand: Col-press Instant Ice Cold Compress
Lot #: 8405-1

Problem:
Multiple reports in past week within this facility for leaking ICE PACK after activation. All leaks identified to one lot number 8405-1. One exposure to eyes occurred requiring follow-up through employee health. Contents: Ammonium Nitrate and Water. No patient involvement. Manager reports that the pack appears to be leaking from back seam of bag.


RADIOLOGY

Device:
Type: Imaging Coil, MRI
Manufacturer: GE Medical Systems, LLC
Model#: 1.5T 16CH BRAIN-SPINE NEUROVASCULAR ARRAY COIL

Problem:
The patient was tubed in order to perform an MRI. The procedure usually lasts two to three hours and the patient felt pain and discomfort which was followed with a bald spot on the top of the head. As in hair cell production rest.

The 16 channel brain-spine neurovascular array coil was used.

~~~~
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.

Additional Information:

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm. FDA Safe Use Initiative. October 13, 2011.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm

Return to Top

Return to Medsun Home


Medical Device Problem Summaries

Summary of MedSun Reports Describing Problem With the Continuous Cardiac Output Pulmonary Artery Catheter

Print Item
E–mail Item

The intended use of continuous cardiac output pulmonary artery catheter and continuous cardiac output monitor systems is for the assessment of the patient's hemodynamic condition though direct intra-cardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for the sampling of venous blood (1).

Over the past year, MedSun has received 28 adverse event reports associated with pulmonary artery catheter devices manufactured by Arrow International, Edwards LifeSciences, and ICU Medical. The reports were submitted by 17 hospitals between January 2011 and December 2011. Please note that several reports contain multiple catheters as well as multiple device problems.

The reported device problems were:
• Inaccurate temperature readings - 9
• Balloon rupture/dislodgement – 5
• No wave form – 5
• Error or fault message - 3
• Cardiac output would not register – 2
• Exposed wires on the catheter - 1
• Balloon would not stay inflated - 1
• Difficulty retracting air – 1
• Air leak – 1
• Inability to read pressures properly – 1
• Catheter would not calibrate – 1
• Fluid leaking from port – 1
• Catheter would not wedge – 1
• Monitor did not recognize the catheter – 1
• Physician did not deflate the balloon before removal -1
• Unknown device issues - 2

One report involved a patient death. In addition, the other reported patient problems are also listed, below. Please note some reports identified multiple patient problems.
• Repeat procedure to insert another Swan-Ganz catheter – 11
• Supraventricular tachycardia (SVT) – 1
• Retained balloon fragment – 2
• Death – 1
• Surgical intervention – 1
• Return for repeat procedure - 1
• Potential for harm – 11
• Unknown – 9

Of the reports that listed patient age, there were no reports with a patient age listed as less than 21 years and 24 reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 6 reports involved female patients and a total of 19 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

There are no recalls related to these devices in the past year.

The following table lists the MedSun reports that are described in the device problem summary above.



MedSun Reports Describing Problems with Continuous Cardiac Output Pulmonary Artery Catheter
Device Manufacturer and BrandDevice Identifiers (Model/Catalog/Lot numbers) Event Description
Edwards LifeSciences/CCOmbo V Device # 1: Lot # 59072561; Device #2: Lot # 59041689

The Swan-Ganz was being inserted via Cordis right (RT) internal jugular (IJ) and twice the balloon broke. The depth of first one was about 60 cm but never got a right ventricular (RV) wave. The second one had the same difficulty. The patient has atrial and mitral prosthetic valves. One Swan-Ganz catheter was tagged and send to central supply for follow up. The patient was maintained with a triple lumen catheter and arterial line. The patient was managed by medical crital care (MCC) and discharged 4 days later.
Edwards LifeSciences/VIP+ Six Lumen Catheter
Model # 834HF75 Cardiac output port came apart between the white connection and the yellow catheter portion leaving exposed wire. When discovered, the catheter was discontinued. The device was not replaced and there was no patient injury.
Edwards LifeSciences/Swan Ganz CCO VIP
Device 1: Model # 139HF75P, Lot # 59003326; Device 2: Model # 139HF75P Lot # 59026127; Device 3: Model # 139HF75P, Lot # 59026127



1st case: open heart case: The surgeon thought the wave forms looked funny and the cardiac index read 10 and there was a fault message about the filaments, Swan changed out during case then worked fine. 2nd case: Patient in OR for open heart surgery, after patient was intubated, the anesthesiologist passed the Swan Ganz which gave pressures on the monitor but was not reading any wave forms. A new Swan Ganz was opened and it worked successfully with all readings coming across the monitor. 3rd case: No patient information, only the swan w/note that state "bad" on sticker.
Edwards LifeSciences/Thermodilution catheter Catalog # 1317P,
Lot # 59053852
Swan Ganz catheter did not sense blood temperature. Unable to use and had to replace it. There were no problems noted in placing the catheter. The patient was discharged in stable condition but is going to have to repeat the procedure to get a definitive diagnosis.
Edwards LifeSciences/ControlCath Model # C146F7
Lot # 58888828
The patient who is status post coronary artery bypass graft (CABG) went to the cath lab for diagnostics due to increasing congestive heart failure and respiratory failure. After the Swan-Ganz Thermodilution Catheter, pulmonary artery catheter, was placed, the doctor attempted to inflate the balloon and the balloon would not stay inflated. The doctor had to place a different catheter. He opened another Swan and had no difficulty with the balloon. The patient did fine; there was no ill-sequelae due to the inability of the balloon to stay inflated.
Edwards LifeSciences/Swan-Ganz PAC VIP Five Lumen
Model # 831F75
The RN was informed of difficulty retracting air. An additional attempt made by the RN. The physicians were informed at this time. An order for critical chest x-ray received at approximately 1 pm. At that time, the monitor shows supraventricular tachycardia (SVT) at 170-210. The house staff were at the bedside. The dobutamine was turned off at this time. Adenosine 6 mg given IV push per physician's order. The patient's heart rate slowed momentarily, then resumed a rate of 140's in atrial flutter. Amiodarone 150mg bolus given at this time per physician's order. The rate slowed to a baseline of sinus tachycardia in 120's. All other vital signs were stable as seen on the flowsheet. The order was received to remove the swan. At approximately 2 pm, the Swan-Ganz catheter was removed, with the balloon fully intact, however, an air leak was noted. The house staff was informed at this time. Cordis left in place and obturator applied. Chest x-ray obtained. It is unknown if episode of SVT was due to the suspected air leak in balloon or from the dobutamine.
Edwards LifeSciences/Swan-Ganz CCO/VIP
Model# 139HF75P
Lot # 58930373
The equipment malfunctioned. Submitting report to clear queue. No further information is available and no action is expected.
Edwards LifeSciences/Swan-Ganz CCO/VIP Catalog # 139HG75P
Lot # 58987967
The Swan Ganz catheter was inserted by the anesthesiologist and was not reading the pressure properly. Device was removed and a second was inserted and was working properly. No other specifics or further information regarding the device malfunction was reported.
Edwards LifeSciences/Swan Ganz CCOmbo Catalog # 746HF8
Lot # 58984700
The catheter would not calibrate. Multiple attempts were made.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen
UNK Checked the pulmonary artery (PA) catheter temperature and it read 104.5. Took the temperature axillary, tempanic, temporal and the readings were 102.4. Called Biomed to check out the monitor and the cables. They found nothing wrong with the cables. The cables and modules were replaced with no change noted. ====================== Manufacturer response for Thermodilution Venous Infusion Port (VIP), Swan Ganz (per site reporter) ====================== They are sending return packaging so the device can be returned to them.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen Model # 831HF75
The ICU nurse was checking the patient's temperature. The readings were off. No exact information available except the PA reading was higher than the tempanic, temporal, and oral reading by a few degrees (2 or 3). The ICU nurse changed out all modules and cables with no apparent changes. Biomed was then called in to examine the monitor and all cables. They found no apparent problems.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen Model # 831HF75
The ICU nurse was checking the patient's temperature. The reading from the Swan Ganz PA Catheter was reading 101 degrees. When the temperature was taken by tympanic, temporal, and orally they registered 97.6 degrees. The nurse changed the cables and modules. Called Biomed and they checked all cables and modules used on the patient. They were all found to be working correctly.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen Model # 831HF75
Lot # 58971113
The patient's Swan Ganz was attached to the GE Marquette monitor. The temperature reading was 104.0 degrees. When the temperature was taken temporally it registered at 98.2 degrees. All cables were changed and the module. This did not change the results. The patient was afebrile. Biomed was called in and the monitor was checked as well as modules and all cables involved. Equipment and cables were found to be in working order.
Arrow International/Arrow Wedge Pressure Cathete Catalog # AI-07127, Lot # MF0095014

Used product, it appeared to perform successful measurements. When removed from patient, it was noticed that the rubber balloon on the end of the catheter was not there.
Edwards LifeSciences/Swan-Ganz CCO
Model # 139HF75P
Swan Ganz CCO/VIP was placed through the Cordis Introducer. When the pulmonary artery line was flushed, fluid came out of the central venous pressure port on the catheter. When the central venous pressure line was flushed, fluid came out of the pulmonary artery port on the catheter. The anesthesiologist removed the line and placed a new one that functioned properly.
Edwards LifeSciences/HiShore TD Model # 141HF7
Patient with congestive heart failure and cardiomyopathy had Swan-Ganz catheter. The catheter was not wedging. The catheter advanced by MD, and an x-ray was obtained to confirm placement. A hemodynamic profile was ordered and the catheter wedged without resistance. Following the wedge, the patient began coughing, initially stable, but rapidly progressed to arrest and patient expired. Patient was being worked up as a VAD and transplant candidate.
Edwards LifeSciences/Swan-Ganz Lot # 58943639, 58943617, 58901477
The doctor attempted to place the Swan Ganz catheter twice. He was not able to obtain the correct wave form on the patient monitor while inserting. Upon discontinuing the catheter, it was noted that the tip of the balloon was ruptured or missing.
Edwards LifeSciences/Swan-Ganz CCO/VIP
Model # 139HF75P, Lot # 58983645
During an open heart case, physician inserting right subclavian sheath with a CCO Swan. When Swan was hooked up the Vigilance II monitor, indicator showed there was something wrong with the connection. Team switched out Vigilance II Monitors and cables and got same message. Clinical Engineering tested cable, all was fine. Swan removed and new one placed and all worked fine.
ICU Medical/UNK Lot # 92-024-2A
A thermodilution catheter (or Pulmonary Artery catheter) allows us to calculate a cardiac output and continuously monitors the temperature of the blood (a patient's core temp). The monitoring difficulties we were having were originally that the monitor was not continuously recognizing the catheter and the cardiac output option would turn on and off by itself. After troubleshooting, we also realized that the temperature reading was fluctuating very quickly from one extreme to the other. After an hour with Medical Engineering, we felt all the monitoring equipment was working correctly and that the problems may be stemming from a damaged thermistor on the catheter itself.
Edwards LifeSciences/Swan Ganz CCO/VIP
Model # 139HF75P, Lot # 58930373

The Swan Ganz catheter was inserted and the anesthesiologist noted that the cardiac output was not registering. A new Swan Ganz catheter was inserted and hooked up to the same equipment and worked properly registering the cardiac output.
Edwards LifeSciences/Swan Ganz CCO/VIP
Model # 139HF75P, Lot # 58878963

Patient had left heart catheterization, coronary angiogram, insertion of swan-ganz and balloon pump. Difficulty advancing the swan and when removal was attempted, the balloon was dislodged. The problem did not occur with initial insertion. It was felt that it happened because there was difficulty and too much pressure was used. Further, the physician did not deflate the balloon before pulling it back. Tried to snare balloon, but unsuccessful. IVC filter placed instead. It is planned that the balloon will be removed once the patient improves and becomes stronger.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75

I spoke with the nurse in the ICU who had the Swan-Ganz catheter. She stated, when the patient first arrived and was hooked up to the physiological monitors, the temperature would register normal thermal 98 degrees. After awhile it would slowly creep up until it registered 104 degrees. She said that they took the tympanic temperature, temple, and orally and they were normal thermal. She even checked the patient to make sure they did not feel warm. She said they changed the cables, module and used a different monitor. None of these changes made a difference. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Sending box in to return and sending a replacement. Will also send report after examination of product.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75
The pulmonary artery catheter (PAC) temperature was 103.8 and did not correlate with the patient's temperature when using other methods. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Called and left detailed message. Waiting for response.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75
The pulmonary artery catheter (PAC) temperature was 103 degrees. The tympanic temperature was 100.7 degrees. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Waiting for them to call back.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75, Lot # 58933168

The pulmonary artery catheter supplied the patient's temperature as being 104 degrees, but the temperature of the patient was between 98-99 degrees. The patient's temperature was checked several different ways. The cables were changed several times which made no difference. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Will notify the company today.
Edwards LifeSciences/Synthetic ControlCath TD Model # C146F7
(listed as other device # in report) Lot # 588875019
Balloon on catheter ruptured in patient's heart during procedure. Latex free Swan-Ganz. Patient had highly calcified vessels. Swan difficult to advance. On fluoroscopy exam, the balloon was found to be ruptured. The balloon appeared intact upon inspection.
Edwards LifeSciences/Swan Ganz CCO/VIP
Model # 139HF75P, Lot # 58915467
Swan Ganz catheter placed in the OR by anesthesiologist prior to emergency coronary bypass surgery. The cardiac output monitor was not functioning. Swan Ganz cable changed but still not monitoring. Swan Ganz catheter replaced after surgery. No patient harm.
Edwards LifeSciences/Swan Ganz CCO SVo2 VIP
Model # 777HF8
Lot # 58943356
Swan catheter was giving a "fault" reading after insertion. The catheter was removed and a new swan was inserted. Other reports of similar 'fault readings".


Additional Information:

1. 510(k) Summary. July 22, 2008. Retrieved from:
http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081776.pdf

Return to Top

Return to Medsun Home

Updated February 1, 2012

Return to MedSun: Medical Product Safety Network

-
-