BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1990297 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01954
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 23, 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 ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A PATIENT REPLACING THE CASSETTE, BUT REUSING THE SOLUTION BAGS COULD NOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR/ MIS-USE. 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. 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 OF A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOME CHOICE (HC) MACHINE DURING DAY FILL 1, THE HOME PATIENT (HP) REVEALED THAT HE HAD ALREADY CHANGED THE CASSETTE, BUT DID NOT CHANGE THE BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP THAT HE WOULD NEED TO START OVER WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. DURING A FOLLOW UP WITH THE HP, IT WAS REVEALED THAT THE PROBLEM WAS WITH THE BAGS, AND THEY WERE NOT ALLOWING THE PROPER FLOW RATE. THE HP STATED THAT HE WAS CAREFUL WHEN RECONNECTING AND LOADING THE NEW CASSETTE AND ADDED THAT HE KNEW HE SHOULD NOT BE DOING THAT DUE TO CONTAMINATION RISKS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HC CYCLER