BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2022355 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03289
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE REPORTED ISSUE OF FLUID WARMING UP TOO FAST & GOT TO WARM WAS UNABLE TO BE CONFIRMED IN THE LOGS AND WAS NOT DUPLICATED DURING THE RITE TESTING. THE CAUSE IS UNDETERMINED. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE HOME PATIENT (HP)'S CAREGIVER (CG) REGARDING A CHECK HEATER LINE ALARM, IT WAS FOUND THAT SHE HAD NOTICED THE BAGS SHE USED ON THE HEATER LINE SEEMED LIKE THEY WARMED UP TOO FAST AND GOT TOO WARM. THE PATIENT WAS INVOLVED, BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE NURSE ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM, IT WAS REVEALED THAT SHE WAS NOT AWARE OF ANY TEMPERATURE ISSUES WITH THE HOME CHOICE (HC) MACHINE. THE NURSE SAID THAT NEXT TIME SHE TALKED TO THE HP SHE WOULD LET THEM KNOW TO CONTACT GLOBAL TECHNICAL SERVICE WITH ANY FURTHER PROBLEMS AT ALL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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