BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19724618 · Received July 11, 2024

    Report

    Report Number
    3003442380-2024-13280
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    April 10, 2024
    Report Date
    July 10, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016958
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). - MDR DEVICE 1 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET FELL OFF DURING USE ON 10-APR-2024, 24-APR-2024, 15-MAY-2024, 28-MAY-2024. THE ISSUE OCCURRED WITH FOUR INFUSION SETS USED FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236181 AUTOSOFT XC UNO INSET I 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001729 6003541 05705244016958

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male