BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2052377 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04421
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 7, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 19 ASSOCIATED WITH THIS DEVICE. THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. EXTERNAL AND INTERNAL VISUAL INSPECTIONS REVEALED NO PROBLEMS. THE DEVICE HISTORY REVIEW REVEALED THE HC DEVICE FAILED THE PNEUMATIC TEST. THE DEVICE WAS REWORKED AND PASSED ALL SUBSEQUENT TESTING PRIOR TO RELEASE. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PEDIATRIC IIPV FOUND IN THE DEVICE LOGS. THE CAUSE OF THE PEDIATRIC IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLES ADVANCING TO THE NEXT FILL WHEN SLOW/ NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2011 DURING DRAIN CYCLE 8. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 150 ML AND THE DRAIN VOLUME WAS 206 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP)'S PERITONEAL DIALYSIS NURSE ON (B)(6) 2011, TO RELAY THE IIPVS FOUND DURING EVALUATION OF THE HC DEVICE. THE NURSE STATED THE HP'S PRESCRIPTION CHANGES FREQUENTLY BECAUSE THE HP IS A BABY. THE NURSE CONFIRMED THE HC WAS NOT USED AS A TRAINING DEVICE. THE NURSE STATED THE HP IS FLOURISHING, GROWING AS HE SHOULD BE, AND HAD NOT SHOWN ANY SYMPTOMS OF IIPV.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO