BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1971649 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01097
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR, AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A USER ERROR. PER THE REPORT, DURING TROUBLESHOOTING, THE PATIENT STATED SHE REMOVED HER CAP, OPENED THE TRANSFER SET AND DRAINED OUT. THIS CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE DETERMINED ROOT CAUSE IS USER ERROR/ MIS-USE. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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 TROUBLESHOOTING, THE HOME PATIENT (HP) STATED SHE REMOVED HER CAP, OPENED THE TRANSFER SET, AND DRAINED OUT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE RISK OF DRAINING IMPROPERLY AND ADVISED THE HP TO CONTACT THE DIALYSIS NURSE TO INFORM THEM OF IMPROPER DRAINING. A FOLLOW UP WAS DONE VIA PHONE CALL. THE NURSE STATED THAT THEY WERE AWARE OF THE PATIENT DISCONNECTING AND DRAINING INCORRECTLY. THEY ARE NOT SURE OF WHAT WAS CAUSING THE DRAINING ISSUES, AND THERE HAVE NOT BEEN ANYMORE SINCE. THERE WAS NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AND THE HP HAS CONTINUED THERAPY WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR HOME CHOICE CYCLER