BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2024194 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03410
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 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). THIS COMPLAINT IS FOR A CHECK LINES AND BAGS ALARM. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS NOT IDENTIFIED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERRORS 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FILL 4. DURING TROUBLESHOOTING, THE HP SAID THAT HE DID MANUAL DRAIN. THE HP SAID THAT HE RESPIKED THE LINE ON THE LAST FILL BAG ON TO THE HEATER LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ABOUT NOT RESPIKING SUPPLY BAG AND ASSISTED WITH ENDING THERAPY. THE TSR ADVISED TO FOLLOW UP WITH NURSE ABOUT PROGRAM AND RESPIKING SUPPLY BAGS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE NURSE STATED THE HP WAS INFORMED ABOUT NOT RESPIKING THE BAGS. THE HP HAS CONTINUED THERAPY NO INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT.

    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 45 YR HOMECHOICE