BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1872722 · Received October 11, 2010

    Report

    Report Number
    1124841-2010-00164
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 23, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO RECEIVED THE CENTRIFUGAL PUMP, BUT NOT THE ACTUAL TUBING THAT BECAME DISCONNECTED FROM THE DEVICE. AN EVALUATION WAS CONDUCTED ON THE TUBING THAT WAS RETURNED BY THE USER FACILITY WITH THE CENTRIFUGAL PUMP, AND IT WAS DETERMINED THAT USER ERROR CAUSED THE DISCONNECTION. 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 THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE INLET TUBING BECAME DISCONNECTED FROM THE CENTRIFUGAL PUMP. THE PROBLEM OCCURRED ON THREE SEPARATE OCCASIONS; HOWEVER, NO EVENT INFORMATION WAS PROVIDED FOR THE OTHER TWO EVENTS. THE PRODUCT WAS CHANGED OUT, THERE WAS LESS THAN 100 CCS 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 MG17

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK