BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5477315 · Received March 3, 2016

    Report

    Report Number
    8010762-2016-00134
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 9, 2016
    Report Date
    February 9, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS DISPOSED OF BY THE HOSPITAL; THEREFORE, IT IS NOT AVAILABLE FOR MANUFACTURER'S LABORATORY INVESTIGATION. MAQUET CARDIOPULMONARY IS AWARE OF A SIMILAR COMPLAINT WHICH WAS INVESTIGATED WITH THE FOLLOWING RESULTS: THE PRODUCT WAS TESTED IN THE LABORATORY OF MAQUET CARDIOPULMONARY FOR ITS DE-AIRING BEHAVIOR (NO AIR ENTRY THROUGH DE-AIRING MEMBRANE) DURING PRIMING ACCORDING TOLV 974 AND IFU QUADROX-I ADULT G-117 VERSION 06. DURING THE WHOLE TESTING PROCESS NO AIR BUBBLE CREATION AND NO AIR ACCUMULATION WAS DETECTED. CONCLUSION: THE FAILURE "AIR COMES THROUGH HYDROPHOBIC FILTER" WAS NOT CONFIRMED. BASED ON THE ABOVE MENTIONED INVESTIGATION RESULTS OF THE SIMILAR COMPLAINT A CONFIRMATION OF THE FAILURE IS NOT POSSIBLE. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE OXYGENATOR WAS NOT POSSIBLE AS THE PRODUCT WAS DISPOSED OF AND THE UDI IS UNKNOWN. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HYDROPHOBIC FILTER IS DEFECTIVE: THIS FILTER ALLOWS AN ENTRY OF AIR GOING TO THE OXYGENATOR DURING THE PRIMING PROCEDURE WITH 2.4L/MIN. THE AIR ENTRY IS OBSERVED WHEN THE RATE IS CHANGED FROM 2.4 TO 0.7L/MIN DURING A PERIOD GOING FROM 1 TO 2 SECONDS ( BUT NOT BY USING 7L/MIN WITH ON/OFF). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133518 HLM TUBING SET W/SOFTLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG HQV 69001 92166861

    Patients

    Seq Age Sex Outcome Treatment
    1