BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1211902 · Received October 23, 2008

    Report

    Report Number
    1124841-2008-00032
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 25, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K915363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS VISUALLY EXAMINED AND LEAK TESTED. THIS EVAL CONFIRMED THE REPORTED LEAKAGE. VISUAL EXAMINATION REVEALED SMALL CRACKS NOTED IN THE CONNECTION OF THE TOP HOUSING. ALTHOUGH THE CAUSE FOR THE CRACKS CANNOT BE DEFINITIVELY DETERMINED, THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A PRE-EXISTING DEVICE DEFECT. ALL UNITS ARE LEAK TESTED DURING PRODUCTION AND THERE WERE NO INDICATIONS OF ANY PRODUCTION RELATED PROBLEMS IN THE DEVICE HISTORY RECORD. A REVIEW OF THE COMPLAINT RECORDS CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE WITH SPECIFIC CAUTIONS TO MONITOR THE PUMP (AND REPLACE) IF THERE ARE FLUID LEAKS OR BLOOD IN THE REAR CHAMBER. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE WITH QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING PRIMING OF THE CIRCUIT, THE PERFUSIONIST NOTICED LEAKAGE FROM THE CENTRIFUGAL PUMPHEAD. THE UNIT WAS CHANGED OUT PRIOR TO THE START OF THE BYPASS PROCEDURE. THEREFORE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. NA KF12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA