BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CB INFANT PACK

    MDR report key: 1033289 · Received April 21, 2008

    Report

    Report Number
    2184009-2008-00014
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    January 20, 2008
    Report Date
    April 14, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K891687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEWED. DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. 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 CAN OR 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 NOT EXPECT TO SEE GREATER THAN 4.815 GRAMS OF HEPARIN PER DEVICE. WE ARE SUBMITTING THE 5-DAY REPORT AS REQUESTED BY FDA, BUT HAVE NOT HAD SUFFICIENT OPPORTUNITY SINCE RECEIVING NOTICE ON APRIL 14, 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 PART OF OUR INVESTIGATION, MEDTRONIC DID NOT DETECT THE CONTAMINANT IN THE HEPARIN 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

    THIS USER FACILITY HAD BEEN NOTIFIED BY FDA THAT MANUFACTURERS AND USERS OF HEPARIN COATED PRODUCTS WERE REQUIRED TO REPORT POSSIBLE HEPARIN RELATED ADVERSE EVENTS. CONSEQUENTLY, THE HOSPITAL REVIEWED THEIR RECORDS, AND IDENTIFIED THAT THIS PEDIATRIC PATIENT HAD UNDERGONE AN ECMO PROCEDURE IN 2008, AND HAD SUBSEQUENTLY DEVELOPED PETECHIAL LESIONS (SMALL RED OR PURPLE SPOTS ON THE SURFACE OF THE SKIN OR MUCOUS MEMBRANES AS THE RESULT OF TINY HEMORRHAGES OF BLOOD VESSELS), PURPURA, HYPERTENSION, AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). THE USER DID NOT BELIEVE THAT THE PRODUCT HAD CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS. THE PT'S CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT PROVIDED. IN RESPONSE TO FDA'S REQUEST, THE USER FACILITY REPORTED THE EVENT TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CB INFANT PACK DTZ MEDTRONIC PERFUSION SYSTEMS CB3W16R3 8664127

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening