BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURY HLM PERFUSION SYSTEM

    MDR report key: 5771228 · Received July 5, 2016

    Report

    Report Number
    3001589655-2016-00002
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 5, 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 ATTEMPTED TO CANCEL THE LEVEL SENSOR TO CONTINUE BUT THE ROLLER STOPPED AND DID NOT RE-START. THE USER THEN USED THE HAND CRANK FOR ABOUT FOUR MINUTES UNTIL THE USER CYCLED POWER TO THE COMPUTER PERFUSION CONTROLLER (CPC), CANCELLED THE LEVEL SENSOR AND THE ROLLER STARTED TO OPERATE TO COMPLETE THE CASE. USE OF THE INSTRUMENT WAS CONTINUED WITH NO RESULTING ADVERSE PATIENT EFFECT. THE SERVICE ENGINEER SHOWED ALMOST IMMEDIATELY AND CHECKED THE MACHINE, TRYING TO SIMULATE THE FAILURE, BUT THE MACHINE AND THE SENSOR WORKED WELL. NO ADVERSE PATIENT EFFECTS REPORTED. NO PATIENT FOLLOW-UP OR REQUIRED TREATMENT NECESSARY, NO ENVIRONMENTAL CONDITIONS EXISTED THAT MAY HAVE INFLUENCED EVENT. A LOANER DEVICE HAS BEEN PROVIDED, BUT REQUESTS TO RETURN SUSPECT DEVICE FOR EVALUATION CONTINUE TO 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
    425418 CENTURY HLM PERFUSION SYSTEM CARDIOVASCULAR BYPASS SYSTEM DTQ CENTURY HLM, LLC CCB40180 CCB40180

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention