BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 3599746 · Received December 4, 2013

    Report

    Report Number
    8021545-2013-00010
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    August 16, 2013
    Report Date
    November 29, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K120872
    Removal / Correction Number
    8021545-11/19/2013-0006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR REPORT HAS BEEN MADE SINCE THIS EVENT HAS LED TO A RECALL. THIS INCIDENT HAS ALREADY BEEN REPORTED TO THE FDA IN THE ASR REPORT FOR (B)(4). IN NOVEMBER 2013, A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT #8021545-11/19/2013-0006. A VISUAL INSPECTION AND A TEST FOR FLOW, LEAK AND STATIC PULL WERE PERFORMED ON THE RETURNED USED DEVICE. THE TUBING WAS DETACHED FROM THE ASANTE CONNECTOR AND FOR THIS CONDITION IT WAS LEAKING. NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-CONNECTOR. THE TUBING WAS DETACHED FROM THE ASANTE RESERVOIR CONNECTOR (7 OUT OF 10). UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH ASANTE SOLUTIONS, THE DISTRIBUTOR OF THE INFUSION SET. (B)(4).

    Description of Event or Problem · 1

    PT WOKE UP THIS MORNING AND WHEN SHE STOOP UP HER PUMP DROPPED TO THE FLOOR. SHE THEN REALIZED THE TUBING HAD PULLED OUT OF THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629563 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4127-5 0230119

    Patients

    Seq Age Sex Outcome Treatment
    1