BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 2883115 · Received December 18, 2012

    Report

    Report Number
    1124841-2012-00130
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE DEVICE, THE COMPLAINT COULD NOT BE CONFIRMED. NO ANOMALIES WERE NOTED DURING VISUAL INSPECTION OR PERFORMANCE TESTING. EVEN THOUGH THE ISSUE COULD NOT BE CONFIRMED, THIS MOST LIKELY OCCURS DUE TO ABNORMAL INTERACTION BETWEEN THE SEAL ROTOR AND STATOR SURFACES. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO A CARDIOPULMONARY BYPASS SURGERY, DURING SETUP, THE CENTRIFUGAL PUMP SQUEALED. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. NA PE02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK