BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECMO PUMP

    MDR report key: 32388 · Received April 29, 1996

    Report

    Report Number
    MW1008965
    Event Type
    Injury
    Date Received
    April 29, 1996
    Date of Event
    April 8, 1996
    Report Date
    April 15, 1996
    Manufacturer
    SORIN BIOMEDICAL, INC.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ECMO PUMP STOPPED FUNCTIONING AFTER "SNAPPING" SOUND HEARD. MANUAL CRANKING WAS REQUIRED WHILE THE PUMP WAS CHANGED. SPLIT BELT CONFIRMED BY BIOMEDICAL ENGINEERING. SECOND SUCH INCIDENT OF BELT BREAKAGE SINCE 1/96. PT'S O2 SATURATION DECREASED, BUT RETURNED TO BASELINE QUICKLY AFTER GOING BACK ON ECMO. ABG'S DURING HAND CRANKING 28/47/72/24. ALL APPROPRIATE PREVENTIVE MAINTENANCE HAD BEEN DONE ON PUMP. BELT WITH NORMAL USAGE TIME, SO SHOULD NOT HAVE SPLIT. RECEIVED NO RECOMMENDATION OR REPORT OF EVALUATION ON PREVIOUS INCIDENT REPORTED 1/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECMO PUMP OXYGENATOR DTZ SORIN BIOMEDICAL, INC. 10-10-00 G

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention