BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID SMALL ADULT/ADULT

    MDR report key: 14432767 · Received May 18, 2022

    Report

    Report Number
    8010762-2022-00176
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    May 13, 2022
    Report Date
    May 18, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE MANUFACTURER IS ONGOING.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A QUADROX OXYGENATOR WAS LEAKING WATER FROM THE HEATER COOLER OUT THE GAS EXHAUST PORT. IT WAS ON A PATIENT FOR LESS THAN AN HOUR WHEN THIS HAPPENED. IT WAS POST DOUBLE LUNG TRANSPLANT PATIENT ON V-V (VENO VENOUS) SUPPORT. PATIENT IS HEP C POSITIVE. THE CUSTOMER CHANGED OUT THE OXYGENATOR. THERE WAS NO COLOR CHANGE TO WATER IT WAS ALL CLEAR. NO CONSEQUENCES TO THE PATIENT EXCEPT FOR THE NEED TO CHANGE OUT THE QUADROX." NO HARM WAS REPORTED. NO PICTURE OF THE LEAKAGE WAS PROVIDED. AS THE PRODUCT WAS NOT AVAILABLE FOR TECHNICAL INVESTIGATION A LABORATORY INVESTIGATION WAS NOT POSSIBLE. THUS IT WAS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED EVENT. THE PRODUCTION RECORDS OF THE AFFECTED OXYGENATOR (3000168944, 3000168434) WERE REVIEWED. FOLLOWING STEPS ARE PERFORMED WITH A 100 % INSPECTION: TIGHTNESS CHECK BLOOD SIDE. TIGHTNESS CHECK WATER SIDE. ACCORDING TO THE FINAL TEST RESULTS, THE OXYGENATOR WITH THE SERIAL# 1947 PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "WATER LEAKAGE GAS EXHAUST PORT" COULD NOT BE CONFIRMED. HOWEVER,ACCORDING TO OUR RISK MANAGEMENT FILE THE REPORTED FAILURE MOST PROBABLE WAS ASSOCIATED WITH A CRACK IN THERMOPLASTIC POLYURETHANE (TPU) HEAT EXCHANGE FIBER. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING H3 OTHER TEXT : 4114.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A QUADROX OXYGENATOR WAS LEAKING WATER FROM THE HEATER COOLER OUT THE GAS EXHAUST PORT. IT WAS ON A PATIENT FOR LESS THAN AN HOUR WHEN THIS HAPPENED. IT WAS POST DOUBLE LUNG TRANSPLANT PATIENT ON V-V (VENO VENOUS) SUPPORT. PATIENT IS HEP C POSITIVE. THE CUSTOMER CHANGED OUT THE OXYGENATOR. (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392163 QUADROX-ID SMALL ADULT/ADULT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HMOD 70000-USA 3000168944

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown