BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMO71000#QUADROX-I

    MDR report key: 3831981 · Received March 7, 2014

    Report

    Report Number
    8010762-2014-00126
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K101153
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. THE MFR HAS NOT RECEIVED THE DEVICE FOR INVESTIGATION. A REQUEST TO OBTAIN THE DEVICE WAS ISSUED. ONCE THE DEVICE BECAME AVAILABLE, THE INVESTIGATION WILL BEGIN TO DETERMINE THE ROOT-CAUSE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH PRESSURE BEFORE OXYGENATOR. THE SET WAS CHANGED. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139496 HMO71000#QUADROX-I MICROPOROUS MEMBRANE OXYGENATOR DTN MAQUET CARDIOPULMONARY AG 70103.1746 70095982

    Patients

    Seq Age Sex Outcome Treatment
    1 NI