BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 7082836 · Received December 5, 2017

    Report

    Report Number
    8010762-2017-00381
    Event Type
    Death
    Date Received
    December 5, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 21, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(6) 31, 76437 (B)(6), GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE PRODUCT WAS REQUESTED FOR RETURN TO THE MANUFACTURER FOR LABORATORY INVESTIGATION BUT THE PRODUCT WAS NOT AVAILABLE . FURTHERMORE A CLINICAL ASSESSMENT WAS REQUESTED, BUT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS STILL PENDING. REFERENCE EXEMPTION #(B)(4).

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE PRODUCT FOR INVESTIGATION BUT THE PRODUCT WAS NOT AVAILABLE. THEREFORE NO LABORATORY INVESTIGATION COULD BE PERFORMED BY THE MANUFACTURER. A REVIEW FOR SIMILAR COMPLAINTS TO BE INVESTIGATED ALREADY WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. THE AVAILABLE INFORMATION HAS BEEN SHARED INTERNALLY WITH GETINGE THERAPY APPLICATION MANAGER. ACCORDING TO THE REPORT, THE PATIENT HAD AN EXTREMELY HIGH RISK OF THROMBOSIS OR ALREADY GENERATED THROMBI IN THE VENOUS VASCULAR SYSTEM. IN THIS CASE, IT WOULD BE QUITE NORMAL THAT THERE ARE POSITIVE PRESSURES OF VENOUS PRESSURE MEASUREMENT. THAT A THROMBUSFORMATION HAS PENETRATED INTO THE ROTAFLOW PUMP OR HAS FORMED OR ENLARGED THERE, SEEMS TO ME MOST LIKELY AMONG THE SPARSE INFORMATION. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. CLOTTING IS A KNOWN PHENOMENON TO MCP AND THE CAUSE OF THIS INCIDENT WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. BASED ON THESE RESULTS AND THE INFORMATION AVAILABLE AT THIS TIME, THE OXYGENATOR IN QUESTION OPERATED WITHIN MCP SPECIFICATIONS. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND NO SYSTEMIC ISSUE COULD BE DETERMINED NO CORRECTIVE ACTION IS NEEDED AT THIS TIME. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS.DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "CLINICIAN WAS CALLED TO UNIT FOR A PATIENT WHO NEEDED VA SUPPORT. THEY WENT ON PUMP AND IMMEDIATELY NOTICED A POSITIVE PVEN. IT SHOULD BE NEGATIVE. AND WITHIN MINUTES THE CIRCUIT HAD CLOTTED. THEY PRIMED ANOTHER CIRCUIT AND A LARGE RIGHT ATRIAL CLOT WAS FOUND. THEY TRIED TO GO ON PUMP AGAIN BUT WITHIN MINUTES THIS CIRCUIT HAD CLOTTED AS WELL. IN FACT, THERE WAS SO MUCH CLOT, THEY WERE PULLING AIR INTO SOLUTION TRYING TO DRAIN THE PATIENT." (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862776 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