BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2830332 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04975
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 CRACKING AND SMOKING FROM THE DEVICE. THE DEVICE PASSED BOTH THE HOMECHOICE RETURNED INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST. A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. INTERNAL AND EXTERNAL VISUAL INSPECTIONS WERE PERFORMED AND NO PROBLEMS WERE FOUND. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE PROBLEM WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE OF THE PROBLEM WAS UNDETERMINED. THE DEVICE WAS SENT FOR NORMAL SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT CRACKLING AND SMOKING ON A HOMECHOICE (HC) DEVICE AFTER USE, PATIENT NOT CONNECTED. THE HOME PATIENT (HP) STATED FLUID LEAKED ONTO THE BACK OF THE HC AND IT STARTED CRACKLING AND SMOKING. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. THE HP WILL HAVE THE NURSE PROGRAM THE NEW HC. 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 WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR