BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1976400 · Received January 27, 2011

    Report

    Report Number
    3003442380-2011-00002
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    August 19, 2010
    Report Date
    January 26, 2011
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL REFERENCE NO IS (B)(4). EVAL SUMMARY, USED DEVICE: ONE USED DEVICE WAS RETURNED FOR EVAL. A VISUALLY INSPECTION AND A LEAK TEST WAS CONDUCTED ON THE USED DEVICE AND THE DEVICE WAS FOUND TO BE WITHIN PRODUCT SPECIFICATION. FURTHERMORE, UNOMEDICAL A/S CONDUCTED A FLOW TEST ON THE USED DEVICE AND THE DEVICE WAS FOUND TO BE CLOGGED IN THE RESERVOIR CONNECTOR NEEDLE. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR EVAL. REFERENCE SAMPLES: THE RETAINED SAMPLES WERE VISUALLY INSPECTED, FLOW AND LEAK TESTED AND FOUND TO BE WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER STATED THAT HER FATHER PASSED AWAY BY A PULMONARY/CARDIAC ARREST IN (B)(6) HOSPITAL, AND SHE WOULD LIKE THE INFUSION SETS TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FDA FPA UNOMEDICAL A/S MMT-397 9201172

    Patients

    Seq Age Sex Outcome Treatment
    1 Death