BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER

    MDR report key: 3823775 · Received February 20, 2014

    Report

    Report Number
    8010762-2014-00063
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    June 28, 2012
    Report Date
    July 4, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE COMPLAINT IS PART OF A CAPA (B)(4) AND HAS NOT BEEN REPORTED DUE TO "OLD" REPORTING POLICIES AND THE OXYGENATOR WITHOUT COATING IS NOT SOLD IN THE US. THE OXYGENATOR ITSELF, INCLUDED IN THE PLS TUBING SET HAS BEEN GLUED WITH THE SAME GLUE AS THE TYPES OF OXYGENATORS WHICH ARE SOLD IN THE US. THE GLUE WAS CHANGED IN (B)(4) 2013 AND THE IMPLEMENTATION WAS VALIDATED IN (B)(4) 2013. SINCE THEN NO FURTHER INCIDENTS RELATED TO CONNECTOR DETACHMENTS WITH THE SAME ROOT CAUSE ARE KNOWN. A F/U REPORT WILL NOT BE ISSUED.

    Description of Event or Problem · 1

    THE BLOOD OUTLET CONNECTOR OF THE OXYGENATOR WAS COMPLETELY DISCONNECTED FROM THE BLOOD OUTLET PLATE. THE INNER PART OF THE BLOOD OUTLET PLATE WAS BROKEN AND IS STILL GLUED ON THE CONNECTOR. THE OXYGENATOR IS AC COMPONENT OF A BE-PLS 2051# PERMANENT LIFE SUPPORT SET PLUS WITH THE LOT #70062965.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106701 BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER D-QUADROX-I DTZ MAQUET CARDIOPULMONARY AG BE-01970311-PLS 70061419

    Patients

    Seq Age Sex Outcome Treatment
    1 NI