BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3102933 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11827
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS OPERATIONAL AND WAS NOT RETURNED FOR EVALUATION. THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV) ISSUE WAS NOT CONFIRMED. THE CAUSE WAS UNDETERMINED. REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A HIGH DRAIN/CALL PD NURSE ALARM ON THE HOMECHOICE (HC). THE HOME PATIENT HAD A NEGATIVE ULTRAFILTRATION (NEG UF) AT THE END OF THERAPY. THE HP CALLED THE NURSE (PDRN) AND THE PDRN ASSISTED THE HP TO PERFORM A MANUAL DRAIN. THE PDRN CONTACTED BAXTER'S TECHNICAL SERVICE REPRESENTATIVE (TSR) WHO EXPLAINED THE HIGH DRAIN ALARM. A HIGH DRAIN ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. 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
    202990 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE