BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3823776 · Received February 20, 2014

    Report

    Report Number
    8010762-2014-00064
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    May 10, 2012
    Report Date
    June 22, 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
    IT
    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. THIS 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 PT UNDERWENT A CARDIAC SURGERY AND THE SAME DAY HE ALSO UNDERWENT AN ECMO PROCEDURE. AFTER 8 DAYS OF USING THE SET WITHOUT ANY PROBLEMS THERE WAS N ARTERIAL CONNECTOR'S DETACHMENT OF THE BE-PLS 2050. AFTER THAT THE TEAM FOCUS ON ECMO PROCEDURE, REPLACED IN EMERGENCY BE-PLS 2050 THAT WAS DAMAGED WITH A NEW CIRCUIT, SO THE ECMO PROCEDURE CONTINUED FOR OTHER 6 DAYS MORE. NO PT INJURY RELATED TO THE DETACHMENT OF THE OUTLET CONNECTOR REPORTED. THE OXYGENATOR IS A COMPONENT OF A BE-PLS 2050 # PERMANENT LIFE SUPPORT SET WITH AN UNK BATCH. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106643 BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER D-QUADROX-I ADULT DTZ MAQUET CARDIOPULMONARY AG BE-01970311-PLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI