BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM SET SET W/BIOLINE COATING

    MDR report key: 7440889 · Received April 18, 2018

    Report

    Report Number
    8010762-2018-00140
    Event Type
    Death
    Date Received
    April 18, 2018
    Date of Event
    March 21, 2018
    Report Date
    July 31, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). THE PRODUCT WAS REQUESTED FOR RETURN TO THE MANUFACTURER FOR LABORATORY INVESTIGATION. ACCORDING TO THE LABORATORY: CLOTS CAN BE CONFIRMED. LEAK TEST PERFORMED. A VERY SEVERE LEAK IN THE VENOUS SENSOR WAS DETECTED. AND DOCUMENTED. CREATING A CYCLE WITH THE CARDIOHELP IS NOT NECESSARY BECAUSE THE VENOUS SENSOR IS LEAKING. A FURTHER EXAMINATION IS CURRENTLY NOT POSSIBLE FOR SECURITY REASONS. CORRESPONDING MEASURES HAVE ALREADY BEEN INITIATED. AS SOON AS THESE MEASURES THE INVESTIGATION CAN BE RESUMED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). ADDED THE LOT # AND EXPIRATION DATE IN SUSPECT MEDICAL DEVICE SECTION.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: IT WAS REPORTED THAT THE CARDIOHELP COMBINED WITH THE HLS SET HAD NO FLOW. THE CUSTOMER REMOVED THE HLS SET AND USED THE HAND CRANK. THE CUSTOMER DECIDED TO PLACE THE HLS SET BACK IN THE CARDIOHELP DRIVE. ONCE THE HLS WAS SET IN THE DRIVE THE ERROR MESSAGE "DISPOSABLE ERROR" WAS DISPLAYED AND NO FLOW WAS GIVEN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281963 HLM SET SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA 70118745

    Patients

    Seq Age Sex Outcome Treatment
    1 Death