BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEQ-HMOD30000

    MDR report key: 3063422 · Received April 12, 2013

    Report

    Report Number
    8010762-2013-00020
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO NON-CONFORMANCES. ACCORDING TO THE INSTRUCTION FOR USE THE UTILIZATION PERIOD OF THIS DEVICE IS RESTRICTED TO 6 HOURS. THE FIRST OXYGENATOR PERFORMED SATISFACTORILY FOR 14 DAYS AND THE SECOND ONE FOR MORE THAN 12 HOURS. THE REPORTED ISSUES ARE KNOWN TO OCCUR UNDER EXTENDED USE. THE SAMPLE HAS BEEN REQUESTED FROM THE CUSTOMER AND A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF THE SAMPLE IS RETURNED OR FURTHER INFORMATION BECOMES AVAILABLE. ITEM MARKED NI ARE UNKNOWN TO US AT THIS TIME. THIS REPORT IS SUBMITTED IN RESPONSE TO USER FACILITY REPORT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER HAD INITIATED ECLS SUPPORT AND ON DAY 14, THE CUSTOMER NOTICED WHAT APPEARED TO BE A FAILING PEDIATRIC QUADROX OXYGENATOR DUE TO PRESSURE DROPS AND FLOWS. THE CUSTOMER CONVERTED TO A SECOND PEDIATRIC QUADROX OXYGENATOR WHICH STARTED TO EXHIBIT INCREASED PRESSURE DROP OVER 100 WITH DECREASED FLOWS AFTER 12 HOURS OF USE. THE PERFUSIONIST STATED THAT AFTER WASH OUT OF THE SECOND UNIT A CLOT WAS NOTED. REF.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158098 BEQ-HMOD30000 OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BEQ-01930311#QUADRO 70073702

    Patients

    Seq Age Sex Outcome Treatment
    1 NI