BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 7203486 · Received January 18, 2018

    Report

    Report Number
    8010762-2018-00026
    Event Type
    Death
    Date Received
    January 18, 2018
    Date of Event
    January 4, 2018
    Report Date
    February 15, 2018
    Manufacturer
    MAQUET MEDICAL SYSTEMS, USA
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISPOSED OFF AT THE HOSPITAL AND THEREFORE NOT AVAILABLE FOR MANUFACTURERS LABORATORY INVESTIGATION. A REVIEW FOR SIMILAR COMPLAINTS WITH LABORATORY INVESTIGATION RESULTS WAS PERFORMED, NO SIMILAR COMPLAINT WAS FOUND. ACCORDING TO REFERENCE COMPLAINT (B)(4) (SAME PATIENT FIRST TUBING SET) THE PATIENT WAS NOT ANTICOAGULATED DUE TO FIB > 1000. ALSO THE DEATH WAS ATTRIBUTED TO PATIENT CONDITION. ACCORDING TO THE IFU HLS SET ADVANCED 7.0 G-670 NO ANTICOAGULATION OR INSUFFICIENT ANTICOAGULATION CAUSED OCCLUSION OF THE EXTRACORPOREAL CIRCULATION AND THE PATIENT CIRCUIT. THIS CAN LEAD TO INADEQUATE PATIENT SUPPORT, HEMOLYSIS OR THROMBUS FORMATION IN THE PATIENT. THUS THE REPORTED EVENT WAS MOST PROBABLE CAUSED BY PATIENT CONDITION / INSUFFICIENT ANTICOAGULATION AND 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. AS NO DEVICE MALFUNCTION WAS CONFIRMED DURING INVESTIGATION AND NO SYSTEMIC ISSUE COULD BE DETERMINED THEREFORE NO CORRECTIVE ACTION IS NEEDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # (B)(4)

    Description of Event or Problem · 1

    REF.: # (B)(4). CUSTOMER REF.: (B)(6). ALSO RELATED TO CUSTOMER REF: (B)(6) FOR FIRST CIRCUIT- MFG REPORT 8010762-2018-00025.

    Description of Event or Problem · 1

    DECISION WAS MADE TO CUT THE CIRCUIT AND START A NEW ONE. AFTER THE HLS SET RELATING TO COMPLAINT (B)(4) WAS REMOVED DUE TO CLOTTING, A SECOND HLS SET WAS UTILIZED. THIS COMPLAINT IS IN REGARD TO THIS SECOND HLS SET. WHEN SUPPORT WAS INITIATED WITH THIS SECOND HLS SET, IT IMMEDIATELY CLOTTED AND THE DECISION WAS MADE TO DISCONTINUE SUPPORT. THIS SECOND HLS SET WAS DISPOSED OF. THE LOT AND SERIAL NUMBER FOR THIS SECOND HLS SET ARE NOT AVAILABLE. THE DEATH WAS ATTRIBUTED TO PATIENT CONDITION AS DICTATED BY THE INITIAL REPORTER. REF.: # (B)(4) CUSTOMER REF.: (B)(4). ALSO RELATED TO CUSTOMER REF.: (B)(4) FOR FIRST CIRCUIT- MFG REPORT 8010762-2018-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48159 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET MEDICAL SYSTEMS, USA BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death