BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2974259 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04462
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SYSTEM ERROR (SE) 2240 DURING PERITONEAL DIALYSIS (PD) THERAPY; THERE WAS NO INFORMATION TO KNOW IF THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT'S NURSE WENT TO TAKE DOWN THE HOMECHOICE (HC) MACHINE AND NOTICED THE ALARM. SHE STATED THE PATIENT HAD ALREADY DISCONNECTED FROM THE MACHINE AND WAS UNABLE TO LET HER KNOW IF HE WAS CONNECTED AT THE TIME OF THE ALARM. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED WITH TROUBLESHOOTING. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. 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
    78332 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE