BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241979 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12012
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 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 COMPLAINT WAS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE HOME PATIENT; THE CASSETTE WAS REPLACED WHILE SOLUTION BAGS WERE REUSED IN RESPONSE TO AN ALARM. 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. A CAUSE WAS UNDETERMINED.

    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 FINAL LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME, THE HOME PATIENT (HP) REVEALED THAT SHE HAD CHANGED OUT THE CASSETTE (ONLY). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE SUPPLIES WERE COMPROMISED AND ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES OR RISK INFECTION. THE HP UNDERSTOOD EXPLANATION AND AGREED TO START OVER WITH NEW SUPPLIES. 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