BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS HARDSHELL CARDIOTOMY RESERVOIR

    MDR report key: 4180536 · Received October 15, 2014

    Report

    Report Number
    8010762-2014-00792
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K090534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS REPLACED DURING PRIMING, DUE TO A BLOOD PATH TO AIR LEAK AT THE ARTERIAL TEMPERATURE PORT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655703 VENOUS HARDSHELL CARDIOTOMY RESERVOIR RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN MAQUET CARDIOPULMONARY AG VKMO 30000 921202957

    Patients

    Seq Age Sex Outcome Treatment
    1