BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PACK TL5A39R3 H-L

    MDR report key: 1111006 · Received August 8, 2008

    Report

    Report Number
    2184009-2008-00062
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. CONCLUSION: ON APRIL 8, 2008, MEDTRONIC WAS NOTIFIED BY FDA THAT A CONTAMINANT HAD BEEN DISCOVERED IN RECENTLY MANUFACTURED HEPARIN. MEDTRONIC MANUFACTURES SEVERAL PERFUSION PRODUCTS THAT ARE COATED WITH CHEMICALS CONTAINING HEPARIN, MANY OF WHICH ARE USED TO MAKE A BYPASS AND/OR ECMO CIRCUIT. IT IS DIFFICULT TO ESTIMATE THE TOTAL QUANTITY OF HEPARIN CONTAINED IN THIS PARTICULAR CIRCUIT, FOR THIS PARTICULAR CASE, HOWEVER WE WOULD EXPECT TO SEE APPROXIMATELY 0.73 MG OF HEPARIN IN A TRILLIUM COATED OXYGENATOR, THE SURFACE AREA OF WHICH ACCOUNTS FOR 2.72 SQUARE METERS OF AN ESTIMATED 3.32 SQUARE METERS IN A TYPICAL BYPASS CIRCUIT. WE ARE SUBMITTING THE 5-DAY REPORT AS REQUESTED BY FDA, BUT HAVE NOT HAD SUFFICIENT OPPORTUNITY SINCE RECEIVING NOTICE ON AUGUST 4, 2008, TO DETERMINE WHETHER THE DEVICE OR THE HEPARIN CONTAINED IN THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. HOWEVER, UPON RECEIPT OF THIS EVENT AND AS A PART OF OUR INVESTIGATION, MEDTRONIC DID NOT DETECT THE CONTAMINANT IN THE HEPARIN SODIUM ACTIVE PHARMACEUTICAL INGREDIENT USED TO COAT THIS PRODUCT LOT WHEN IT CONDUCTED ITS TESTING IN ACCORDANCE WITH RECOMMENDATIONS CONTAINED IN FDA'S APRIL 8, 2008 NOTIFICATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT SHORTLY AFTER DELIVERING 4:1 BLOOD CARDIOPLEGIA (300 TO 400CC PER DOSE), THIS PATIENT EXPERIENCED BRIEF HYPOTENSION DOWN TO APPROXIMATELY 20 MMHG. IT WAS NOTED THE RESPONSE WAS MORE PROFOUND WITH REPEAT DOSES OF CARDIOPLEGIA, RATHER THAN THE INITIAL DOSE. THE PERFUSIONIST INDICATED THAT THEY HAD OBSERVED THE HYPOTENSION INTERMITTENTLY SINCE EARLY 2008; HOWEVER, ATTRIBUTED IT TO ANESTHESIA. THE PATIENT'S CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT PROVIDED. IT WAS UNKNOWN WHETHER SYSTEMIC INTRAVENOUS HEPARIN OR SUBCUTANEOUS HEPARIN WAS ADMINISTERED DURING, OR IN PROXIMITY TO, THE USE OF THIS TRILLIUM COATED CIRCUIT. ADDITIONAL INFORMATION RECEIVED NOTED THE PERFUSIONIST'S AT THIS FACILITY HAVE OBSERVED THE HYPOTENSION WITH SEVERAL PATIENTS, 17 IN TOTAL. IT WAS NOTED THAT THE HYPOTENSION WAS NOT OBSERVED WHILE USING ANOTHER MANUFACTURER'S PRODUCT. IN ALL CASES, THE PATIENTS WERE TREATED WITH NEOSYNEPHRINE, RESOLVING THE ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO 13 OF THE CASES HAVE BEEN UNSUCCESSFUL. THE CUSTOMER CIRCUIT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PACK TL5A39R3 H-L CUSTOM CIRCUIT DWB MEDTRONIC PERFUSION SYSTEMS TL5A39R3 9991458

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R MEDTRONIC DID NOT DETECT THE CONTAMINANT IN THE| LOT 9991458| HEPARIN USED TO COAT THIS PRODUCT LOT| MODEL TL5A39R3| TRILLIUM COATED CUSTOM CIRCUIT