BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMU 40 BLOOD MONITORING UNIT

    MDR report key: 3810771 · Received March 21, 2014

    Report

    Report Number
    8010762-2014-00149
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DRY
    PMA / PMN Number
    K090147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. IT WAS REPORTED THAT THE SERIAL # OF THE ARTERIAL SENSOR AND VENOUS CELL WERE DISCARDED BY THE CUSTOMER. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SUPPORT OF A PATIENT ON EXTRACORPOREAL LIFE SUPPORT, THE BLOOD MONITORING UNIT BLOOD VALUES / PARAMETERS STOPPED BEING DISPLAYED. THE UNIT WAS TURNED OFF AND BACK ON, BUT NO VALUES WERE DISPLAYED. THE DEVICE HAD BEEN IN USE CONTINUOUSLY FOR 23 DAYS OF SUPPORT. NO PATIENT EFFECT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169825 BMU 40 BLOOD MONITORING UNIT BMU40 DRY MAQUET CARDIOPULMONARY AG 70104.0852 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI