BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 6170038 · Received December 13, 2016

    Report

    Report Number
    8010762-2016-00717
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    December 5, 2016
    Report Date
    March 1, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION; THEREFORE MANUFACTURERS LABORATORY INVESTIGATION WAS NOT POSSIBLE. AT THIS TIME NO SIMILAR COMPLAINT INVESTIGATED WAS FOUND WHICH COULD LED TO THE CONFIRMATION OF THE FAILURE AND / OR A PRODUCT RELATED MALFUNCTION. THE MOST PROBABLE CAUSE OF THE INCIDENT IS ACCORDING TO THE EVENT DESCRIPTION THAT THE CIRCUIT AND THE MEMBRANE CLOTTED OFF AND THEREFORE THE BLOOD FLOW STOPPED. THE COMPLAINT (B)(4) REFERS TO A CASE OF A PATIENT UNDER ECMO SUPPORT WHERE THE FLOW OVER AN OXYGENATOR STOPPED, CHANGEMENT OF THE OXYGENATOR WAS POSSIBLE, BUT THE DECISION WAS TO STOP EXTRACORPOREAL SUPPORT DUE TO ETHICAL DISCUSSIONS WITH THE FAMILY OF THE PATIENT. THE DEVICE WAS NOT SENT FOR FURTHER INVESTIGATION. AS ¿CLOTTING¿ IS A COMMON RISK FOR EXTRACORPOREAL CIRCUITS, MORE INFORMATION ON THE ANTICOAGULATION, BLOOD PARAMETERS OF THE COAGULATION SYSTEM AND CLINICAL STATE OF THIS PATIENT WOULD BE NECESSARY TO DILIGENTLY ANALYZE IF A CLOT HAD OCCURRED OR NOT. A REPLACEMENT OF THE OXYGENATOR WAS POSSIBLE, BUT NOT PERFORMED DUE TO THE ABOVE MENTIONED REASONS. THE PATIENT DIED DUE TO THE DECISION NOT TO REPLACE THE OXYGENATOR AND NOT TO CONTINUE EXTRACORPOREAL SUPPORT. THIS IS A DECISION OF THE MEDICAL TEAM AND THE FAMILY, WE DO NOT SEE THAT THIS IS RELATED TO A PRODUCT FAILURE. BASED ON THESE RESULTS THE CAUSE OF THE REPORTED INCIDENT WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. DUE TO THIS AND THE FACT THAT NO SYSTEMIC ISSUE COULD BE DETERMINED NO CORRECTIVE ACTIONS WILL BE PERFORMED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE DEVICE IS NOT AVAILABLE FOR MANUFACTURER'S LABORATORY INVESTIGATION. THE INVESTIGATION BY THE MANUFACTURER IS ONGOING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "CUSTOMER STATES CARDIOHELP PUMP STOPPED DELIVERING FLOW. THEY ALSO STATED "SOME CLOTS WAS VISIBLE IN THE CIRCUIT".THE PT¿S HEMODYNAMICS AND BLOOD GASES WERE STABLE AFTER THE PUMP STOPPED AND PERFUSION OFFERED TO WET DOWN ANOTHER HLS SET, BUT DR (B)(6) DECLINED DUE TO THE FAMILY WISHES. WITH THAT SAID, THE PT DID EXPIRE LATER THAT NIGHT." "THE DISPOSABLE WAS DISCARDED AND THE CUSTOMER IS UNSURE OF LOT #S AND SERIAL #S, SO PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. CUSTOMER DID STATE THAT ¿SOME¿ CLOT WAS VISIBLE IN THE OXYGENATOR AND IN THE AVALON CANNULA." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823355 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death