BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2183239 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09931
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS CONFIRMED IN THE LOGS, BUT WAS NOT DUPLICATED DURING THE PAL EVALUATION. THERE WAS NO FAILURE OR MALFUNCTION IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOGS. THE CAUSE OF THE IIPV IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE EXCESSIVE DRAIN; UNEXPECTEDLY HIGH ULTRAFILTRATION FOR THE THERAPY COMPARED TO OTHER THERAPIES. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE CAREGIVER (CG) REPORTED THE DRAIN VOLUME WAS 4401ML IN DRAIN 5 OF 6. THE PROGRAMMED FILL VOLUME IS 1300ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED WOULD SWAP AND ADVISED THE CG TO CALL THE NURSE TO ADVISE. THE CG WOULD CALL FOR PROGRAMMING ASSISTANCE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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