BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120978 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07497
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF THE COMPLAINT IS USE ERROR. LABEL REVIEW WAS PERFORMED AND THE 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A CHECK FINAL LINE ALARM THAT APPEARED ON HOME CHOICE (HC) DURING PRIME. THE HOME PATIENT (HP) STATED THAT SHE CHANGED TOUT THE CASSETTE BUT NOT THE BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED THE HP WHEN CHANGING OUT THE CASSETTE THE BAGS NEEDED TO BE CHANGED OUT AS WELL AND THEN HAD THE HP START OVER WITH ALL NEW SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. A FOLLOW UP WAS DONE VIA PHONE. THE NURSE SAID SHE WAS NOT AWARE OF THE USE ERROR. THE WRITER EXPLAINED THE CALL MADE BY THE HP AND RECOMMENDED RETRAINING. THE NURSE SAID SHE HAD NOT HEARD FROM THE HP SINCE HER LAST CLINIC VISIT BUT TO HER KNOWLEDGE THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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 55 YR HOME CHOICE