BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLS SET ADVANCED 7.0

    MDR report key: 10892227 · Received November 24, 2020

    Report

    Report Number
    3008355164-2020-00023
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 22, 2020
    Report Date
    February 8, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION RECORDS OF THE HLS MODULE WERE REVIEWED AND ACCORDING TO THE FINAL TEST RESULTS, THE OXYGENATOR WITH THE SERIAL# (B)(6) PASSED THE TEST AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. THE HLS SET WAS INVESTIGATED IN THE LABORATORY ON 2021-01-30: DURING VISUAL INSPECTION NO ABNORMALITIES WERE DETECTED. A LEAK TEST OF THE WATER AND BLOOD SIDE WAS PERFORMED WHICH REVEALED NO LEAKAGES. FURTHER THE PUMP WAS TESTED AND NO ISSUE WERE NOTED. NO TECHNICAL CAUSES FOR THE DEVELOPMENT OF BLOOD CLOTS WERE FOUND. FOR FURTHER INVESTIGATION AS MEDICAL ASSESSMENT WAS PERFORMED BY MANAGER MEDICAL AFFAIRS WITH FOLLOWING RESULTS: PROTAMIN WAS ADMINISTERED AFTER CPB BUT NEITHER THE DOSE NOR THE MODE OF ADMINISTRATION ARE KNOWN. IT IS ALSO NOT KNOWN IF ADDITIONAL PROTAMIN WAS ADMINISTERED WHEN COAGULATION TESTING AFTER APPLICATION OF PROTAMIN STILL SHOWED AN ACT OF 243 SECONDS. ESSENTIAL DATA SUCH AS INFORMATION ON THE ADMINISTRATION OF BLOOD PRODUCTS AND/OR COAGULATION FACTORS HAVE NOT BEEN PROVIDED. ACT MEASUREMENTS WERE NOT PERFORMED AT THE TIME OF ECLS START, DURING THE 45 MINUTE PERIOD ON ECLS, AT THE TIME WHEN CLOTTING OF THE OXYGENATOR AND A DECREASE IN BLOOD FLOW WERE NOTICED, OR AT THE TIME WHEN THE DEVICE WAS REPLACED AND ECLS THERAPY WAS STARTED WITH A NEW DEVICE. NO INFORMATION HAS BEEN PROVIDED ON THE STATUS/SYSTEM PARAMETERS OF THE CARDIOHELP SYSTEM DURING THE 45 MINUTE PERIOD OF ECLS. THE INFORMATION AVAILABLE DOES NOT ALLOW IDENTIFICATION OF A REASON FOR CLOTTING. FOLLOWING POSSIBLE ROOT CAUSES COULD LEAD TO THE REPORTED FAILURE: INSUFFICIENT ANTICOAGULATION. SUBSTITUTION OF BLOOD PRODUCTS. PATIENT PRE CONDITION. BASED ON THE INVESTIGATION RESULTS NO MALFUNCTION OF THE PRODUCT 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 · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION FROM THE FACTORY BECOMES AVAILABLE. FACTORY NOTIFIED IMPORTER ON (B)(6) 2020 THAT THIS WAS DEEMED A SERIOUS INJURY.

    Description of Event or Problem · 1

    45 MIN AFTER INITATE ECLS-THERAPY BLOOD CLOTTED IN THE OXYGENATOR, SYSTEM STOPPED AND BECAUSE THE CIRCULATION OF THE PATIENT WAS COMPLETELY DEPENDEND FROM THE CARDIOHELP-SYSTEM, HEART LUNGS RESUSCITATION WAS NEEDED DURING THE TIME OF HLS-SYSTEM CHANGE. HEART LUNGS RESUSCITATION WAS SUCCESSFUL, AT THE MOMENT NO PATIENT DAMAGE IS EXPECTED. COMPLAINT ID:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361029 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 Required Intervention