BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1880077 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04774
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    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). THIS COMPLAINT IS FOR A REPORT OF A CHECK SUPPLY LINE. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION THEREFORE THE COMPLAINT CANNOT BE CONFIRMED IN THE LAB. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS USER ERROR. 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 FOR THE CHECK SUPPLY LINE ALARMS IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS RESOLVED OVER THE PHONEA FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING LAST FILL, THE HOME PATIENT (HP) REPORTED THAT HIS CAREGIVER (CG) REMOVED HAD THE HEATER BAG BECAUSE SHE THOUGHT THE THERAPY WAS COMPLETED. WHEN THE CG REALIZED THE THERAPY WAS NOT COMPLETED, SHE ADDED A NEW BAG. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ADVISED THE HP THAT THEY WOULD NEED TO END THERAPY BECAUSE OF THE BAG BEING REMOVED AND THE NEW ONE BEING ADDED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE CG REGARDING THE REPORTED ISSUE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND THAT IT WAS AN ACCIDENT. THE CG STATED THAT SHE DISCUSSED THE ISSUE WITH THE NURSE. PER CG, HP IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 55 YR