BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1981344 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01631
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE HAS BEEN DISCARDED AFTER USE AND IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF USER ERROR. THE REPORTED CONDITION WAS NOT CONFIRMED IN THE LAB DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS MIS-USE. THE PATIENT STATED THAT SHE ONLY WANTED TO CHANGE THE CASSETTE AND WILL NOT CHANGE THE BAGS. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICES (GTS) REGARDING A RELOAD THE SET 202 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT. THE HP STATED SHE WAS NOT CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HP STATED THAT SHE WOULD NOT CHANGE THE BAGS. THE TSR EXPLAINED THE RISK OF CONTAMINATION. THE HP FURTHER STATED THAT SHE ONLY WANTED TO CHANGE THE CASSETTE. NO FURTHER DETAIL IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE APD SYSTEM/REF (B)(4)