BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1160590 · Received September 11, 2008

    Report

    Report Number
    1124841-2008-00027
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 14, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, WHICH LIMITS THE FAILURE INVESTIGATION. A RETENTION SAMPLE FROM THE SAME LOT WAS TESTED AND NO DEFECT WAS FOUND. 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 INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A SMALL BLOOD LEAK FROM THE CENTRIFUGAL PUMP DURING A BYPASS PROCEDURE. THE PERFUSIONIST DETERMINED THAT IT WAS NOT NECESSARY TO CHANGE OUT THE UNIT OR TAKE ANY OTHER CORRECTIVE ACTION TO ADDRESS THIS OBSERVATION. THE CASE WAS REPORTEDLY COMPLETED WITH NO COMPLICATIONS OR PATIENT INJURIES. THE REPORTED BLOOD LOSS WAS ESTIMATED TO BE 1-CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. NA HN12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK