BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 5998940 · Received October 4, 2016

    Report

    Report Number
    8010762-2016-00602
    Event Type
    Death
    Date Received
    October 4, 2016
    Date of Event
    August 3, 2016
    Report Date
    September 26, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION WAS REQUESTED, BUT THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. SEVERAL ATTEMPTS WERE PERFORMED, BUT WE HAVEN¿T GOT ANY TRACKING INFORMATION OR A CONFIRMATION IF THE PRODUCT WILL BE SENT BACK. HOWEVER, THE FAILURE IS KNOWN AND WAS THOROUGHLY INVESTIGATED UNDER CAPA (B)(4). THE LOT OF THE OXYGENATOR WAS FOUND TO BE IN THE RANGE OF CAPA (B)(4) (FIBER LOT 14-02959 TO LOT 14-2960. SIMILAR PRODUCTS HAVE BEEN TESTED AND UNDER OPTICAL MICROSCOPE DELAMINATION OF SOME GAS FIBERS WERE OBSERVED. HENCE, THE PRIMING SOLUTION OR BLOOD WAS ABLE TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE AND THE GRAVITY GUIDED IT TO THE GAS EXITING PATH ALONG THE HOUSING. THE INVESTIGATION UNDER CAPA PROCESS (CAPA (B)(4)) HAS IDENTIFIED THAT THE ROOT CAUSE IS DUE TO THE MANUFACTURING PROCESS OF THE (B)(4) MATERIAL FIBERS USED IN THE OXYGENATOR. IF, DURING THE SURFACE PRE-TREATMENT, A SYSTEM MALFUNCTION RESULTS IN A SYSTEM STOP, THE ENTIRE LENGTH OF THE FIBER IS NOT PROPERLY TREATED TO MODIFY THE SURFACE TENSION. IF THESE UNTREATED FIBERS ARE PRESENT IN THE EPOXY AREA OF THE OXYGENATOR, IT IS NOT PROPERLY FIXED IN THE EPOXY. WHEN THIS OCCURS, THE FIBERS ARE ABLE TO ¿SHRINK OUT¿ OF THE EPOXY AND RESULT IN THE REPORTED LEAKAGE. THE RAW MATERIAL MANUFACTURER HAS INITIATED STEPS TO REPEAT THE SURFACE PRE-TREATMENT TO ENSURE THAT THE PROPER SURFACE TENSION IS PRESENT ON THE ENTIRE LENGTH OF THE FIBERS. CAPA (B)(4) EFFECTIVENESS: THE CAPA (B)(4) WAS CLOSED AS TO BE EFFECTIVE BASED ON 12 MONTHS PERIOD UNDER OBSERVATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED FOR RETURN BUT NOT YET RECEIVED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "THE PRODUCT FAILED IN THE 6TH DAY OF USE, WHERE A RUPTURE IN THE MEMBRANE WAS IDENTIFIED CAUSING A FORMATION OF A FOAM COMPOSED BY THE MIXTURE OF GAS AND BLOOD ON THE OXYGENATOR'S GAS OUTLET CONNECTOR. THE OXYGENATOR WAS REPLACED IMMEDIATELY." "THE PATIENT IS DEAD, BUT ACCORDING TO THE CLINICAL STAFF, IT WAS NOT RELATED TO THE PROBLEM BUT DUE THE CLINICAL CONDITIONS OF THE PATIENT. THE PROBLEM IS PROBABLY RELATED TO A MEMBRANE RUPTURE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650309 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BE-PLS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death