BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 8264696 · Received January 21, 2019

    Report

    Report Number
    8010762-2019-00016
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    January 11, 2019
    Report Date
    February 13, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6).

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. REFERENCE EXEMPTION # E2018002. IMPORTER: (B)(4).

    Description of Event or Problem · 0

    REF.: #(B)(4), CUSTOMER REF.: #(B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: "CLOT FORMATION IN ARTERIAL FILTER AT FULL HEPARINIZATION DURING ECC WASTE OF THE ARTERIAL SATISFACTION, WITHOUT THE BLOOD FLOW WAS REDUCED, OR NO INCREASE DELTA P OXYGENATOR CHANGE OF HLM INCL. SET" REF.: #(B)(4), CUSTOMER REF.: #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56089 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HQV 1806-1 92260005

    Patients

    Seq Age Sex Outcome Treatment
    1