BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 3599747 · Received December 4, 2013

    Report

    Report Number
    8021545-2013-00007
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    May 1, 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
    Adverse Event
    Yes
    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 Q2 2013. 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 (TUBING-ASANTE CONNECTOR) WERE PERFORMED ON THE RETURNED USED DEVICE. THE TUBING WAS DETACHED FROM THE ASANTE CONNECTOR. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-ASANTE CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECS. NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-ASANTE CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECS. UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH (B)(4), THE DISTRIBUTER OF THE INFUSION SET. THE INTERNAL REFERENCE NUMBER FOR THIS COMPLAINT AT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PT STATED THAT THEIR INFUSION SET GOT CAUGHT ON AN ARM CHAIR AND WHEN HE GOT UP OUT OF THE CHAIR, THE INFUSION SET DISCONNECTED FROM THE TUBING CONNECTOR. PT STATES THE TUG WAS MODERATE AND NOT SEVERE. WE HAVE ASKED THE PT TO SEND BACK THE INFUSION SET AND TUBING CONNECTOR FOR INSPECTION (HAS NOT BEEN RECEIVED YET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629797 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4123-5 0230118

    Patients

    Seq Age Sex Outcome Treatment
    1