BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3063012 · Received April 17, 2013

    Report

    Report Number
    1416980-2013-09515
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 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 CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS AND BATCH REVIEW CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2367 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THE ALARM TO THE HOME PATIENT (HP) HAD HER CLOSE ALL OF THE CLAMPS AND TURN THE HC OFF. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE HP UNDERSTOOD AND SAID THAT SHE DID NOT DO ANYTHING DIFFERENTLY AND DID NOT NOTICE ANYTHING DIFFERENT CONCERNING THE SUPPLIES. THERE WAS NOTHING FOUND DURING TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT 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
    164057 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE