BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3180672 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16034
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. DURING DEVICE HISTORY RECORD REVIEW FAILURE OF PNEUMATIC TEST WAS IDENTIFIED. THE HOMECHOICE (HC) MACHINE WAS REWORKED AND IT PASSED ALL SUBSEQUENT TESTING. THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) RECEIVED A HIGH DRAIN 103 ALARM ON THE HOMECHOICE (HC) MACHINE DURING USE, WHILE THE HP WAS NOT CONNECTED. THE HIGH DRAIN ALARM INDICATES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE HP HAD DISCONNECTED ASEPTICALLY BEFORE CONTACTING TECHNICAL SERVICE REPRESENTATIVE (TSR). THE HP DID NOT HAVE ANY SYMPTOM OF INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE TSR HAD THE HP CYCLE THE POWER TO CLEAR THE ALARM. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280781 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE