BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1845038 · Received September 13, 2010

    Report

    Report Number
    1124841-2010-00121
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND THE INVESTIGATION CONFIRMED THE CENTRIFUGAL PUMP WAS NOISY. THE NOISE WAS THE RESULT OF PARTICULATES ACCUMULATED ON THE SEAL SURFACE. THE OBSERVED HAZE IN THE IMPELLER WAS FROM A NEW BONDING AGENT USED IN THE MANUFACTURING OF THE DEVICE. THE INTAKE OF AIR WAS NOT CONFIRMED, NOR WERE ANY LEAKS IN THE DELPHIN PUMP HEAD OBSERVED. 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 THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE CENTRIFUGAL PUMP WAS MAKING A SQUEALING SOUND. WHEN THE USER FACILITY TURNED OFF THE PUMP, IT WAS OBSERVED THAT AIR WAS BEING DRAWN INTO THE DELPHIN PUMP HEAD AND THERE WAS A HAZE IN THE MIDDLE OF THE IMPELLER. THE USER FACILITY REPORTED THAT THE PUMP WAS CHANGED OUT WITHOUT DELAY TO THE PROCEDURE, AND THAT 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