BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1980002 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01557
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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). A QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CHECK HEATER LINE ALARM. THIS REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS DUE TO ONE OF THE SUPPLY BAGS NOT FULLY SPIKED (IMPROPER SETUP). THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A CHECK HEATER ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING FILL 1. (B)(4) INSTRUCTED THE HP WITH TROUBLESHOOTING. THE HP STATED THE HEATER LINE CAME UNATTACHED FROM THE HEATER BAG. (B)(4) ADVISED THE USE OF NEW SUPPLIES. ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THAT THE SUPPLIES CAME SEPARATED BECAUSE SHE BELIEVED SHE HAD NOT CONNECTED THEM ALL THE WAY WHEN SHE SET UP. THE HP SAID SHE WAS USING THE SPIKE TYPE OF SUPPLIES AT THE TIME. THE HP CONFIRMED SHE DID NOT SEE ANYTHING UNUSUAL WITH THE SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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 53 YR HOMECHOICE APD SYSTEM (B)(4)