BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3093522 · Received May 6, 2013

    Report

    Report Number
    1416980-2013-11380
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED. A LABELING REVIEW FOUND THAT ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) REPORTED AT THE END OF THERAPY ON THE HOMECHOICE (HC), THERE WAS A POWER FAILURE AND THE HP SHUT THE HC OFF, THEN TURNED THE HC BACK ON AND RE-PRIMED USING THE SAME SUPPLIES, WHICH IS INDICATIVE OF A USER ERROR. THE HP HAD THE HC SHUT OFF WHEN THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE TO HER. THE TSR REVIEWED THE ALARM LOG AND A RELOAD SET MESSAGE WAS FOUND. THE TSR ASSISTED THE HP TO OPEN THE DOOR TO TAKE THE CASSETTE OUT. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196829 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE