BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2202657 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10581
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED; AND WAS DETERMINED TO BE CAUSED BY USE ERROR; THE PATIENT DISCONNECTED AND THEN RECONNECTED BAG DURING THERAPY. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION FOR THE CHECK SUPPLY LINE ALARM IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING FILL, THE HOME PATIENT (HP) REVEALED THAT SHE HAD ACCIDENTLY CONNECTED FINAL BAG TO SUPPLY LINE, SO SHE DISCONNECTED A FULL BAG AND RECONNECTED IT TO THE HEATER LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AND ADVISED TO CONTACT NURSE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 HOMECHOICE AND BAG