BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1893499 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05469
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 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). THE ISSUE WAS RESOLVED OVER THE PHONE. THIS WAS AN INCIDENT INVOLVING A USER ERROR AND THERE WAS NO ALLEGATION AGAINST THE BAXTER PRODUCT; THEREFORE THE SAMPLE WILL NOT BE REQUESTED FOR EVALUATION. 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 WAS UNKNOWN. A CAUSE WAS NOT IDENTIFIED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR OF HOME PATIENT ACCIDENTALLY PULLING THE HEATER LINE OUT WHILE TRYING TO RESOLVE THE ALARM. 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 CAPA (B)(4).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A CHECK LINES & BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME (PATIENT NOT CONNECTED), THE HOME PATIENT (HP) REVEALED THAT HE ACCIDENTLY PULLED-OUT THE HEATER LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT SUPPLIES WERE THEN COMPROMISED AND ADVISED HP TO START OVER WITH NEW SUPPLIES. THE HP UNDERSTOOD EXPLANATION AND WOULD START OVER WITH NEW SUPPLIES. DURING A FOLLOW UP WITH THE HP REGARDING PULLING-OUT THE HEATER LINE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND HE HAD RESUMED THERAPY. THE HP CONFIRMED THAT THERE WERE NO DEFECTS ON THE SUPPLIES. THE HP VERIFIED THAT HE HAD ACCIDENTALLY PULLED THE TUBING OUT. 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 71 YR