BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET

    MDR report key: 5105155 · Received September 25, 2015

    Report

    Report Number
    8010762-2015-01063
    Event Type
    Death
    Date Received
    September 25, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 1, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K053025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION BASED ON AVAILABLE INFO AT THIS TIME WAS PERFORMED. A CLINICAL ASSESSMENT WAS PERFORMED BY THE MFR. NO MALFUNCTION OF THE HLS SET COULD BE FOUND. THE INVESTIGATION PROCESS, IF A TREND OCCURS, IT WILL BE ESCALATED TO QA MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER INVESTIGATION. INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) RECEIVED THE PRODUCT BACK FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WHERE IT WAS NOTICED THAT THE BLOOD INLET TUBE AND THE BLOOD OUTLET TUBE WERE CLOGGED WITH BLOOD. AFTER THE CLOGGED BLOOD WAS REMOVED, THE OXYGENATOR WAS FLUSHED FROM BLOOD OUTLET SIDE. THEREBY CLOTS WERE RINSED OUT ON BLOOD INLET SIDE. OXYGENATOR WAS CLEAN AFTER IT WAS CLEANED TWO TIMES WITH NATRIUMHYPOCHLORIT. THE OXYGENATOR WAS OPENED UP BY USING A SAW. THE MATS WERE VISUAL INSPECTED. NO CLOTTING BETWEEN THE MATS WAS FOUND. BASED ON THE RECEIVED INFORMATION AND OUR INVESTIGATION THE FAILURE COULD BE CONFIRMED. THE REPORTED CLOT, WHICH CAME FROM THE PATIENT COULD BE CONFIRMED. BECAUSE BY FLUSHING THE OXYGENATOR BLOOD CLOTS HAVE BEEN RINSED OUT FROM BLOOD INLET SIDE. AS THERE WERE NO CLOTS BETWEEN THE MATS INSIDE THE OXYGENATOR THE FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. FURTHERMORE A DEVICE HISTORY RECORD WAS PERFORMED. NO REFERENCE WAS FOUND, WHICH INDICATED A NONCONFORMANCE OF THE PRODUCT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG (B)(4). THE DEVICE HAS BEEN REQUESTED FOR RETURN . A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS ON A PUMP FOR 18 HOURS AND THE CIRCUIT CLOTTED UP. THE CLOT ORIGINATED FROM THE PATIENT. IT IS BELIEVED TO BE A PULMONARY EMBOLISM OR DEEP VEIN THROMBOSIS THAT WAS SUCKED INTO THE CIRCUIT. THE DEVICE WAS NOT REPLACED. TREATMENT WAS NOT DELAYED. THE PATIENT EXPIRED. THE DEATH WAS REPORTEDLY NOT PRODUCT RELATED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634579 HLM TUBING SET TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death