BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H 105700#TUBING SET

    MDR report key: 4756882 · Received May 5, 2015

    Report

    Report Number
    8010762-2015-00431
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    April 12, 2015
    Report Date
    April 5, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K001787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE LEAKAGE BETWEEN HOUSING AND COVER CAN BE CONFIRMED. THE MOST PROBABLE ROUTE-CAUSE: BAD BONDING AT THE CONNECTION BETWEEN COVER AND THE HOUSING. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED. MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON RECEIPT OF FURTHER INFO. (B)(4); COMPONENT LOT#: 70099859; 510(K)#: K082544.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING ECC, AFTER FEW MINUTES TO START ECC PROCEDURE, ARTERIAL FILTER QUART STARTED TO LEAK, THEY CHANGED FOR THE NEW ONE TUBING SET H 105700. NO PATIENT INJURY WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294367 H 105700#TUBING SET DWE, DTM DWE MAQUET CARDIOPULMONARY AG 00175#QUART 92147086

    Patients

    Seq Age Sex Outcome Treatment
    1