BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIO INFUSION SET

    MDR report key: 6078367 · Received November 4, 2016

    Report

    Report Number
    3003442380-2016-00016
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    May 26, 2016
    Report Date
    November 4, 2016
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K051264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATED 04-NOV-2016: A VISUAL INSPECTION AND TESTS FOR FLOW, LEAK AND VENTILATION TO THE PCC RESERVOIR CONNECTOR WERE PERFORMED ON THE RETURNED USED DEVICE (1 TUBING). ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE CLAIMED FAILURE CANNOT BE CONFIRMED. AN INVESTIGATION HAS BEEN PERFORMED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND ONE RETURNED USED TUBING. IF NEW INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    (B)(4). A DIABETIC PATIENT DECEASED ON (B)(6) 2016. THROUGH THE INVESTIGATION ON THIS INCIDENT NO ADDITIONAL INFORMATION WAS PROVIDED EXCEPT THAT THE PATIENT WAS DECEASED. NO COPY OF THE DEATH CERTIFICATE OR AUTOPSY REPORT WAS PROVIDED. NO CLINICAL CONSEQUENCES BEFORE THE PATIENT PAST AWAY WAS REPORTED. NO LOT INFORMATION AVAILABLE. NO INFUSION SET MALFUNCTION REPORTED. NO HOSPITAL NAME AND OR HCP NAME REPORTED. NO INFORMATION ABOUT IF PATIENT RECEIVE ANY MEDICAL TREATMENT UP TO THE TIME OF DEATH WAS REPORTED. . THE CORONER WAS SUPPOSED TO CONTACT (B)(4) (DISTRIBUTOR) WITH ADDITIONAL INFORMATION. BUT THERE WAS NO CALL BACK FROM THE CORONER. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731860 MIO INFUSION SET MIO INFUSION SET FPA UNOMEDICAL A/S MMT-965 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death