BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1901303 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05873
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 23, 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION 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 CHECK LINES AND BAGS ALARM WAS NOT CONFIRMED. THE PRODUCT WAS NOT RETURNED TO BAXTER FOR EVALUATION. IT WAS NOT POSSIBLE TO REVIEW MANUFACTURING RECORDS FOR THE LOT BECAUSE THE LOT NUMBER IS UNKNOWN. THE CAUSE OF THE CHECK LINES AND BAGS ALARM WAS USE ERROR - THE HOME PATIENT'S REPORT THAT A SPIKE WAS NOT FULLY PUSHED IN. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR 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 LINES AND BAGS ALARM IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK LINES AND BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME, THE HOME PATIENT (HP)'S CAREGIVER (CG) REVEALED THAT THE SPIKE WAS NOT ALL THE WAY IN, AS HE WAS ABLE TO PUSH-IN THE SPIKE FURTHER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE CG AND ASSISTED TO RESUME PRIME. DURING A FOLLOW UP WITH THE CG REGARDING THE CONNECTION ISSUE, THE CG EXPLAINED THAT THERE WERE NO LOOSE CONNECTION ISSUES OR DEFECTS ON THE SUPPLIES; RATHER IT WAS HIS "CARELESSNESS" IN NOT VISUALLY VERIFYING A COMPLETE CONNECTION AFTER SPIKING THE BAG. THE CG STATED THAT THE TSR POINTING THIS OUT TO HIM MADE HIM REALIZE THAT HE HAD NOT ALWAYS BEEN VISUALLY VERIFYING THE CONNECTION. THE CG STATED THAT HE HAS LEARNED FROM HIS MISTAKE, AND HAS NOT HAD ANY PROBLEMS SINCE. PER CG, HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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 83 YR