BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1943337 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07508
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 9, 2010
    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). REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT. EXTERNAL & INTERNAL VISUAL INSPECTIONS REVEALED NO PROBLEMS. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PEDIATRIC IIPV IN THE LOGS. A DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE DEVICE WAS DETERMINED TO MEET THE SPECIFICATIONS RELATIVE TO THE IIPV IDENTIFIED VIA DEVICE LOG REVIEW. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE CAUSE OF THE PEDIATRIC IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO USE ERROR; THE CLINICIAN INAPPROPRIATELY SET THE MINIMUM DRAIN VOLUME PERCENTAGE SETTING TOO LOW (80%). A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2010 DURING DRAIN CYCLE 6. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 500 ML AND THE DRAIN VOLUME WAS 739 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP)'S NURSE TO NOTIFY HER OF THE IIPV FOUND DURING EVALUATION. THE NURSE STATED THAT THE HP HAS A HIGH URINE OUTPUT AND WHEN THE ALARM SOUNDS, THE HP'S MOTHER BYPASSES. THE NURSE STATED THAT THE HP'S MOTHER HAS NOT REPORTED ANY OVER FILL SYMPTOMS AND AGREED TO TALK TO THE HP'S MOTHER REGARDING THIS ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE