BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1872720 · Received October 11, 2010

    Report

    Report Number
    1124841-2010-00167
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K020998
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO RECEIVED THE ACTUAL DEVICE AND THE COMPLAINT WAS NOT CONFIRMED. THE PUMP WAS PERFORMANCE TESTED, AND THE FLOW RATES WERE ACCEPTABLE. IT WAS DETERMINED THAT USER ERROR CAUSED THE INCIDENT. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS LOT. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE CENTRIFUGAL PUMP WAS PRODUCING LOW FLOW RATES THROUGHOUT THE CASE. THE PRODUCT WAS CHANGED OUT, THERE WAS A SLIGHT AMOUNT OF BLOOD LOSS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA MG21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK