BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2001251 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02440
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). 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 & INTERNAL VISUAL INSPECTIONS REVEALED NO PROBLEMS. THE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE UNDETERMINED DUE TO ADDITIONAL THERAPIES BEING PERFORMED OVERWRITING THE PREVIOUS DATA. A SERVICE HISTORY REVIEW REVEALED THAT NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE IIPV. 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 1. THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 73 ML, INDICATING THE HOME PATIENT (HP) DRAINED 73 ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 100 ML. THIS MEANT THE TOTAL DRAIN VOLUME WAS 173 ML, WHICH MEETS THE IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE NURSE TO NOTIFY HER OF THE INCIDENT OF IIPV THAT WAS FOUND DURING THE DEVICE LOG REVIEW. HOWEVER, THE NURSE REVEALED THAT THE PATIENT HAD DISCONTINUED THE USE OF THE HC DEVICE BY (B)(6) 2010 AS HE WAS RECEIVING A TRANSPLANT. THE NURSE STATED THAT SHE HAD RETURNED THE DEVICE TO BAXTER SOON AFTER, AND THAT NO OTHER PATIENT HAD USED THE HC DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1