BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING - SET INCL. HMO 71000

    MDR report key: 4698330 · Received April 14, 2015

    Report

    Report Number
    8010762-2015-00366
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT AND AN INTERNAL PROCESS (CAPA (B)(4)) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT-CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. HOWEVER SINCE THE PRODUCT WAS DISCARDED BY THE HOSP, WE WILL NOT BE ABLE TO CONFIRM THE FAILURE IN THE PRODUCT IN QUESTION AND THEREFORE WILL NOT ABLE TO PROVIDE A ROOT-CAUSE FOR THIS SPECIFIC EVENT. THE DATA IS 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 INFO: THE PRODUCT MENTIONED IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-I) IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAKAGE OR PRIMING FLUID WAS NOTICED FROM THE GAS OUTLET OF THE OXYGENATOR. THE PRODUCT WAS REPLACED AND HAS NOT BEEN USED ON A PATIENT. NO CONSEQUENCES TO THE PATIENT WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247059 CUSTOM TUBING - SET INCL. HMO 71000 DWE, DTZ DWE MAQUET CARDIOPULMONARY AG 70105.3388 92142771

    Patients

    Seq Age Sex Outcome Treatment
    1