BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX D

    MDR report key: 2570659 · Received May 3, 2012

    Report

    Report Number
    8010762-2012-00011
    Event Type
    Death
    Date Received
    May 3, 2012
    Date of Event
    March 16, 2012
    Report Date
    April 4, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. AS REPORTED BY THE FACILITY, THE MAQUET OXYGENATOR WAS ONE COMPONENT OF THE ECMO SYSTEM USED DURING THE EVENT, I.E., THE SYSTEM ALSO CONSISTED OF A FRESENIUS FILTER, A TERUMO TUBING SET AND A CIRCULATORY BETTER BLADDER. THE OXYGENATOR IS NOT BEING RETURNED AT THIS TIME AS THE FACILITY IS CONDUCTING AN INVESTIGATION. MAQUET REQUESTED THAT THE PRODUCT BE RETURNED FOLLOWING THE FACILITY'S INVESTIGATION AND WILL PROVIDE A SUPPLEMENTAL REPORT IF THE PRODUCT IS RETURNED FOR EVALUATION. AFTER REVIEW OF OUR COMPLAINT RECORDS THIS ISSUE APPEARS TO BE AN ISOLATED INCIDENT AS THERE HAS BEEN NO OTHER COMPLAINTS REPORTED OF FREE AIR IN THE LINE. MFR. REPORT # 8010762-2012-0001. (B)(4). UF/IMPORTER REPORT# (B)(4). REFERENCE # : (B)(4). THE FACTORY HAS REVIEWED THEIR COMPLAINT RECORDS FOR "FREE AIR IN THE LINE" AND DETERMINED NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED. THIS APPEARS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE MAQUET OXYGENATOR WAS IDENTIFIED AS A "CONCOMITANT MEDICAL PRODUCT" IN THE MEDWATCH REPORT FILED BY THE FACILITY DATED (B)(6) 2012 AND RECEIVED BY MAQUET ON (B)(4) 2012. PER THE FACILITY'S REPORT, THE "PT HAD BEEN ON ECMO FOR AN EXTENDED PERIOD OF TIME. PT SUFFERED FROM SEVERE LEUKEMIA. DURING ECMO, THE STAFF OBSERVED FREE AIR IN THE LINES AND ATTEMPTED TO REMEDY. PT O2 LEVELS DROPPED SIGNIFICANTLY. THE PT WAS NOT ABLE TO BE RESUSCITATED AND WAS PRONOUNCED." DEVICES REPORTED IN USE DURING THE EVENT: FRESENIUS-POLSULRONE FILTER. CONCOMITANT MEDICAL DEVICES: MAQUET - OXYGENATOR QUADROX D. TERUMO-TUBING SET. CIRCULATORY TECHNOLOGY-BETTER BLADDER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX D NONE DTQ MAQUET CARDIOPULMONARY AG HMOD2030 70048087

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death