BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2220472 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11098
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 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). 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 UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USE ERROR WAS CONFIRMED: THE DISPOSABLE SET WAS REPLACED WHILE THE SOLUTION BAGS WERE REUSED. THE CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK LINES & BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME, THE HOME PATIENT (HP) REVEALED THAT HE HAD CHANGED OUT THE CASSETTE ONLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT SUPPLIES WERE COMPROMISED AND ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE HP UNDERSTOOD EXPLANATION AND WOULD START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP REGARDING THE ALARM, IT WAS REVEALED THAT THEY DID REPLACE THE CASSETTE WHEN THEY CHANGED OUT ALL OF THE SUPPLIES. THE HP REFUSED TO PROVIDE ANY FURTHER INFORMATION.

    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 63 YR HOMECHOICE AND BAG