BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 7775260 · Received August 11, 2018

    Report

    Report Number
    2916596-2018-03389
    Event Type
    Malfunction
    Date Received
    August 11, 2018
    Date of Event
    October 14, 2011
    Report Date
    June 9, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Removal / Correction Number
    FA-Q318-MCS-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURNED FOR ANALYSIS. THE COMPLAINT INVESTIGATION DETERMINED THE REPORTED DIFFICULTY WAS THE RESULT OF A DESIGN RELATED WEAR ISSUE. AFTER REVIEW OF THIS EVENT AND SIMILAR INCIDENTS, ABBOTT HAS DECIDED TO INITIATE A VOLUNTARY FIELD ACTION FOR CENTRIMAG. ABBOTT PERFORMED A COMPREHENSIVE INVESTIGATION WHICH INCLUDED DEVICE ANALYSIS, MANUFACTURING EVALUATION AND TREND ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRIMAG MOTOR WAS NOT BEING DETECTED BY VARIOUS PRIMARY CONSOLES DURING A TECHNICAL SECURITY CHECK OF THE MOTOR. NO PATIENT WAS INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EVENT WAS PREVIOUSLY NOT REPORTED DUE TO NO PATIENT INVOLVEMENT. ABBOTT MADE THE DECISION ON JULY 13, 2018 TO INITIATE A VOLUNTARY RECALL, THEREFORE THIS EVENT IS BEING UPGRADED TO REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616549 CENTRIMAG MOTOR, OUS PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1