BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2981222 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04813
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) FOR THE REPORTED ISSUE OF A SHORT CIRCUIT FROM THE DEVICE (PER THE HOME PATIENT, A HEATER BAG WAS LEAKING ONTO THE DEVICE). THE PROBLEM WAS CONFIRMED IN THE SAMPLE EVALUATION. THE CAUSE OF THE PROBLEM WAS FLUID INGRESS. THE DIGITAL PRINTED CIRCUIT BOARD (PCB) WAS SCRAPPED TO RESOLVE THE ISSUE. THE DEVICE WAS SENT FOR SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SHORT CIRCUIT ON A HOMECHOICE (HC) DEVICE DURING PRIMING, PATIENT NOT CONNECTED. THE HOME PATIENT (HP) STATED THE MACHINE WAS IN PRIMING AND HP LEFT THE ROOM. THE HP'S DAUGHTER CAME IN TO THE ROOM AND SAW THE HEATER BAG WAS LEAKING ON TO THE MACHINE. WHEN THE HP CAME BACK IN THE ROOM SHE STATED THE LIQUID HAD LEAKED INTO THE MACHINE CAUSING IT TO SHORT OUT, AT WHICH POINT THE HP TURNED THE DEVICE OFF. NO ONE WAS HARMED BY THE INCIDENT. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. 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
    83876 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR