BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B/F WARM SET HIGH FLOW CE

    MDR report key: 4907081 · Received July 10, 2015

    Report

    Report Number
    0001831750-2015-00343
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 6, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    KZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT A LIKELY CAUSE FOR THIS ISSUE IS USING A PUMP IN SERIES WITH THE DEVICE CREATING A GREATER THAN SPECIFIED PRESSURE WHICH CONTRIBUTED TO THE CASSETTE LEAK.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT THE MEDITEMP FLUID WARMER CASSETTE RUPTURED DURING USE. IT WAS ALLEGED, THE CASSETTE WAS PRIMED IN THE USUAL MANNER WITH NORMAL SALINE AND THEN USED TO INFUSE BLOOD INTO THE PATIENT AS PER HOSPITAL PROTOCOL. THE CASSETTE RUPTURE OCCURRED WHILST THE HOSPITAL STAFF WERE INFUSING BLOOD INTO A PATIENT. IT WAS ALLEGED, THE SURGICAL PROCEDURES WERE DELAYED/PROLONGED DUE TO THE THEATRE STAFF HAVING TO LOCATE ANOTHER MEDITEMP BLOOD WARMER AND CASSETTE AND SET UP A NEW BLOOD INFUSION FOR PATIENT. IT WAS ALLEGED THAT PROLONGED RECOVERY TIME FOR PATIENT POST OPERATIVELY, DUE TO DELIVERY OF BLOOD AT LESS OPTIMAL TEMPERATURE.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT THE MEDITEMP FLUID WARMER CASSETTE RUPTURED DURING USE. IT WAS ALLEGED THE CASSETTE WAS PRIMED IN THE USUAL MANNER WITH NORMAL SALINE AND THEN USED TO INFUSE BLOOD INTO THE PATIENT AS PER HOSPITAL PROTOCOL. THE CASSETTE RUPTURE OCCURRED WHILST THE HOSPITAL STAFF WERE INFUSING BLOOD INTO A PATIENT. IT WAS ALLEGED THE SURGIAL PROCEDURES WERE DELAYED/PROLONGED DUE TO THE THEATRE STAFF HAVING TO LOCATE ANOTHER MEDITEMP BLOOD WARMER AND CASSETTE AND SET UP A NEW BLOOD INFUSION FOR PATIENT. IT WAS ALLEGED THAT PROLONGED RECOVERY TIME FOR PATIENT POST OPERATIVELY, DUE TO DELIVERY OF BLOOD AT LESS OPTIMAL TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450129 B/F WARM SET HIGH FLOW CE DEVICE, WARMING. BLOOD AND PLASMA KZL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1