BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2132284 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07748
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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 REPORTED ISSUE WAS NOT CONFIRMED. A CAUSE OF THE REPORTED DIFFICULTY COULD NOT BE DETERMINED. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    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 HOME PATIENT (HP) REPORTED A LOW DRAIN VOLUME ALARM IN THE INITIAL DRAIN. THE HP STATED DRAINED OUT 3850ML THIS AFTERNOON THEN FILLED WITH 2000ML. THE INITIAL DRAIN VOLUME WAS 1284ML. THE TSR DID A MANUAL DRAIN AND ONLY GOT OUT 4ML. THE HP STATED FELT EMPTY. THE TSR BYPASSED THE HP TO FILL 1. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON 6 JUNE 2011 PRODUCT SURVEILLANCE CONTACTED THE HP'S PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE PDN VERIFIED THE HP?S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 2000ML.

    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