BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET

    MDR report key: 4657547 · Received April 1, 2015

    Report

    Report Number
    8010762-2015-00327
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U MEDWATCH WILL BE SEND AFTER RECEIVING THE PRODUCT AND EVALUATION. ADDITIONAL INFO: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510(K): K102919.

    Description of Event or Problem · 1

    TRANSLATION FROM THE ORIGINAL INCIDENT REPORT IN (B)(6): NO BLOOD FLOW IN THE RESERVOIR AFTER 30 MIN. HLM TIME. THE PATIENT HAD TO BE CONNECTED TO ANOTHER HLM SET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214850 HLM TUBING SET DTZ, DWE DTZ MAQUET CARDIOPULMONARY AG BO-HQV 16043 92148387

    Patients

    Seq Age Sex Outcome Treatment
    1