BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2050424 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04370
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 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. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USER ERROR. THE PATIENT REPLACED THE CASSETTE; HOWEVER, REUSED THE SOLUTION BAGS. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THE COMPLAINT WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS USE ERROR. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. A ROOT CAUSE INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOMECHOICE (HC) ALARMING A CHECK LINES AND BAGS ALARM. THIS SITUATION OCCURRED DURING PRIME. THE HOME PATIENT (HP) STATED SHE CHANGED THE CASSETTE AND WAS STILL GETTING THE SAME ALARM. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ASKED THE HP IF SHE CHANGED THE BAGS WHEN SHE CHANGED THE CASSETTE AND THE HP STATED NO. THE TSR EXPLAINED THE SETUP WAS COMPROMISED. THE TSR INSTRUCTED THE HP TO CYCLE THE POWER AND CLOSE ALL THE CLAMPS. THE TSR INSTRUCTED THE HP TO DISCARD THE BAGS AND CASSETTE AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR HOMECHOICE