BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET ADVANCED 7.0

    MDR report key: 11145379 · Received January 11, 2021

    Report

    Report Number
    8010762-2021-00006
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 18, 2020
    Report Date
    February 24, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING TREATMENT CLOTTING OF ECMO OXYGENATOR, FOLLOWED BY RISE IN INTERNAL PRESSURE (PINT) AND DELTA P OCCURRED , RESULTING IN REDUCTION OF FLOWS IN USED ECMO CIRCUIT. THE HLS SET WAS REPLACED. THE REPORTED CLOTS LEAD TO A BLOCKAGE AND THUS AN INCREASED DELTA PRESSURE AND REDUCED FLOW. ACCORDING TO OUR RISK MANAGEMENT FILE (HLS SET ADVANCED 5.0 / HLS SET ADVANCED 7.0, DMS # 1468452, V26) FOLLOWING MOST POSSIBLE ROOT CAUSES CAN LEAD TO CLOTTING: 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. THE PRODUCTION RECORDS OF THE AFFECTED HLS MODULE (DMS#2941189 AND 2956715 ) WERE REVIEWED ON (B)(6) 2021. FOLLOWING TESTS ARE PERFORMED ACCORDING TO THE BOP AS A 100 % INSPECTION: LEAK TEST AFTER WELDING; PRESSURE TEST HEAT EXCHANGER; LEAK TEST WATER SIDE; LEAK AND FLOW TEST GAS SIDE; PRESSURE TEST BLOOD SIDE; COATING TEST. ACCORDING TO THE FINAL TEST RESULTS, ALL OXYGENATORS PASSED THE TEST AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE ¿CLOTTING¿ COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE 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 · 0

    COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN HLS MODULE CLOTTED DURING USE AND FLOW WAS REDUCED. THE HLS SET WAS REPLACED DURING TREATMENT. COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46440 HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050#HLS SET ADVANCED 7.0 70138118 (HLS MODULE)

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR