BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2134017 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07856
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED WHEN THE CUSTOMER CONTACTED BAXTER TO TROUBLESHOOT THE ISSUE. A CAUSE FOR THE REPORTED ISSUE WAS UNDETERMINED. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S NURSE REGARDING THE REPORT OF PROGRAM CHANGED BY DEVICE. THE NURSE STATED THAT SHE WAS NOT SURE WHAT HAD CAUSED THE CHANGE IN THE PATIENT THERAPY, HOWEVER, SHE THINKS THAT THE PATIENT MIGHT HAVE PRESSED THE WRONG BUTTON WHILE USING THE MACHINE AT HOME. THE NURSE SAID THAT SHE GOT THE PROGRAM BACK TO TIDAL AND THE PATIENT HAD BEEN CONTINUING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    A NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING "POWER RESTORED" ON THE HOME CHOICE (HC) MACHINE DURING FILL 1 OF 62. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE FILL VOLUME (FV) = 0 ML. THE RN STATED THE HOME PATIENT (HP) PRESSED STOP WHEN THE HC WENT TO FILL AND SHE HAD THE HP CYCLE THE POWER. THE RN STATED SHE TRIED TO END THE THERAPY BUT WAS NOT ABLE TOO. THE RN STATED THE HP SHOULD ONLY HAVE 4 CYCLES. THE TSR EXPLAINED THAT THE HP WILL NEED TO END THE THERAPY TO START OVER WITH ALL NEW SUPPLIES. THE RN REQUESTED TO REVIEW THE PROGRAMMING. THE TSR ASSISTED THE RN WITH REVIEWING THERAPY. THE RN STATED THAT THE SETTING WAS NOT CORRECT. THE TSR ASSISTED THE RN TO PROGRAM THE DEVICE. THE RN STATED THE HP WOULD START OVER WITH ALL NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR