BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

    MDR report key: 4398997 · Received January 5, 2015

    Report

    Report Number
    8010762-2014-01403
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Date of Event
    November 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K090511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE QUALITY CONTROL PROCESS INDICATES THAT A 100% FUNCTIONAL INSPECTION FOR LEAKAGE IS PERFORMED DURING MANUFACTURING. THIS SHOULD BE ADEQUATE TO DETECT PRODUCTS THAT DO NOT MEET THE PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE FOR FINAL PACKAGING AND STERILIZATION. THE TEST IS CARRIED OUT AT 1 BAR )- 14 PSI) FOR A TIME PERIOD OF 75 MIN AT A FLOW OF 10 /1MIN. DURING THIS TIME EACH OXYGENATOR IS CHECKED FOR ANY LEAKS. MAQUET (B)(4) RECEIVED THE OXYGENATOR SAMPLE FOR EVALUATION ON NOVEMBER 18, 2014. AFTER PERFORMING THE LEAKAGE TEST ACCORDING TO THE STANDARD PROCEDURE, LEAKAGE FROM DE-AIRING PORT WAS OBSERVED. THESE RESULTS BECAME AVAILABLE ON DECEMBER 08, 2014. MAQUET (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT AND INTERNAL PROCESS (B)(4) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT-CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND INVESTIGATION PROCESS. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED, IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-I AD) IS REGISTERED UNDER 510 (K): K090511. MRB: MATERIAL REVIEW BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING, AIR REMAINS ON THE VENOUS SIDE OF THE DEVICE AND DOES NOT EXIT VIA THE DE-AIRING MEMBRANE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3389 BE-VEMO 7000 #QUADR-I HMO70000+VHK7100 MICROPOROUS MEMBRANCE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70106-4563

    Patients

    Seq Age Sex Outcome Treatment
    1