BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURY HLM PERFUSION SYSTEM

    MDR report key: 5760571 · Received June 29, 2016

    Report

    Report Number
    3001589655-2016-00001
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    December 4, 2015
    Report Date
    June 29, 2016
    Manufacturer
    CENTURY HLM, LLC
    Product Code
    DTQ
    PMA / PMN Number
    K770002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN ELECTRONIC CARDIOPULMONARY PERFUSION CONSOLE MADE FOR REUSE AFTER EACH PROCEDURE. DURING PROCEDURE, THE DEVICE STOPPED AFTER ALARM, THE USER PROCEEDED TO "CANCEL THE ALARM AND LEVEL BUBBLE" BUT THE PUMP DID NOT RESTART. THE CASE WAS COMPLETED USING THE HAND CRANK. NO ADVERSE PATIENT EFFECTS REPORTED. NO PATIENT FOLLOW-UP OR REQUIRED TREATMENT NECESSARY, NO ENVIRONMENTAL CONDITIONS EXISTED THAT MAY HAVE INFLUENCED EVENT. LOCAL BIOMEDICAL SERVICE PERFORMED A COMPLETE PREVENTATIVE MAINTENANCE PROCEDURE ON SUSPECT DEVICE, DEVICE WAS TESTED AND OPERATED WITH NO ISSUES FOUND. A LOANER DEVICE HAS BEEN PROVIDED, BUT REQUESTS TO RETURN SUSPECT DEVICE FOR EVALUATION HAVE BEEN DENIED.

    Description of Event or Problem · 1

    DEVICE STOPPED AFTER ALARM AND WAS ABLE TO BE RESTARTED PER INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413675 CENTURY HLM PERFUSION SYSTEM CARDIOVASCULAR BYPASS SYSTEM DTQ CENTURY HLM, LLC CPBX158741 CPBX158741

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention