BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET ADVANCED 7.0

    MDR report key: 11145459 · Received January 11, 2021

    Report

    Report Number
    8010762-2021-00007
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    November 13, 2020
    Report Date
    January 11, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Report Source
    Manufacturer report
    Reporter Location
    AE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION RECORDS OF THE AFFECTED HLS MODULE (DMS# (B)(4)) WERE REVIEWED ON 2021-01-08. ACCORDING TO THE FINAL TEST RESULTS, ALL OXYGENATORS PASSED THE TEST AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. THE PATIENT WAS INFECTED WITH COVID-19. COVID-19 DISEASES CAN BE ASSOCIATED WITH INTRAVASCULAR COAGULATION ACTIVATION, MICROCIRCULATION DISORDERS AND INCREASED RISK OF THROMBOEMBOLISM DESPITE GOOD SYSTEMIC ANTICOAGULATION. DUE TO THE HIGH RISK OF SPREADING THE SARS-COV-2 VIRUS OUTSIDE THE HEALTHCARE ENVIRONMENT, A TECHNICAL INVESTIGATION OF THIS HLS SET IS NOT POSSIBLE AS THE LABORATORY OF MAQUET CARDIOPULMONARY (B)(4) IS NOT SUITABLE FOR WHO RISK GROUP 3. FURTHERMORE, NO EXTERNAL LABORATORY COULD BE FOUND THAT COULD CARRY OUT THE INVESTIGATION ON OUR BEHALF. A SIMILAR CASE WAS ALREADY INVESTIGATED UNDER COMPLAINT#(B)(4) ON 2020-06-05: AS STATED IN THE INVESTIGATION REPORT OF OT#(B)(4) CLOTS COULD BE FOUND INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE COULD BE DETERMINED AS CLOTS WHICH CAN LEAD TO A BLOCKAGE AND THUS AN EXTENSION OF THE DIFFUSION PATH LOWERING THE OXYGENATING PERFORMANCE. WITH REFERENCE TO THE RISK ASSESSMENT (HLS SET ADVANCED 5.0 / HLS SET ADVANCED 7.0, DMS # (B)(4), V26) AND IN CONSULTATION WITH THE MANAGER MEDICAL AFFAIRS THE FOLLOWING EVENTS CAN CONTRIBUTE TO CLOTTING IN THE CIRCUIT: DE-AIRING LUER LOCK CONNECTION TOO LOOSE, AIR REMAINS IN OR ENTERS THE CIRCUIT, HEMOSTASIS, AIR OR BLOOD REMAINS IN LUER LOCK ACCESS PORT, TOO LOW ANTICOAGULATION, TOO LOW AT LEVEL, EFFECT OF HEPARIN IS TOO LIMITED, PROTAMINE SULFATE ENTERS THE HLS SET, ADMINISTRATION OF SUBSTITUTION OF CONGEALABLE SUBSTANCE SUCH AS PLATELES, (CONSUMPTION) COAGULOPATHY, THROMBOZYTOPENIA. BASED ON THIS THE REPORTED FAILURE COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 1

    CLOTTING OF ECMO OXYGENATOR DURING VENO-VENOUS ECMO FOR COVID 19. RISE IN INTERNAL PRESSURE (PINT) FOLLOWED BY REDUCTION OF FLOWS.APTT MAINTAINED BETWEEN 50 TO 60. KIT USED HLS 7.0. V-V ECMO INITIATED ON (B)(6) 2020. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43278 HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR