BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMOD70000#QUADROX-ID

    MDR report key: 3894169 · Received February 6, 2014

    Report

    Report Number
    8010762-2014-00033
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE REPORTED LACK OF EFFICIENCY WAS CAUSED BY EXCEEDING SERVICE/SHELF LIFE OF THE QUADROX-ID OXYGENATOR. IT HAD BEEN USED FOR 24 DAYS; HOWEVER, IT IS CLEARLY STATED IN IFU G-152 2013-09, PAGE 4 "THE APPLICATION DURATION IS LIMITED FOR 6 HOURS," THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A PATIENT WAS ON VENO-VENOUS SUPPORT WITH A QUADROX-ID ADULT OXYGENATOR, THE CLINICIANS HAD THE PERCEPTION THE OXYGENATOR LACKED "EFFICIENCY." THE OXYGENATOR HAD BEEN IN USE FOR 24 DAYS OF SUPPORT. UPON COMMENCEMENT OF WEANING THE PATIENT OFF SUPPORT, THE FIO2 WAS TURNED DOWN. WHEN TURNED BACK UP THE NEXT DAY, THE OXYGENATOR DID NOT PERFORM AS IT HAD PREVIOUSLY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2014- THE PATIENT'S CONDITION HAD DECLINED SOME OVERNIGHT. RETURNED TO 100% AND P02S WERE RUNNING MID 200S. THE PATIENT EXHIBITED HIGH ACIDOIS AND THE DOCTORS WERE STUMPED AS TO WHERE IT WAS ORIGINATING FROM. REF#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78423 HMOD70000#QUADROX-ID DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70105.3815 70093196

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR