BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1981354 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01632
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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). THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. 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 SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION; THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. THE PATIENT WAS CONNECTED DURING PRIME. 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 REPORT HAS BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM THAT OCCURRED ON THE HOMECHOICE (HC) DURING PRIMING. THE CG STATED THAT THE HOME PATIENT (HP) WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG THAT THE HP SHOULD NOT BE CONNECTED DURING PRIMING AND TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE CG WHO STATED THIS WAS AN ISOLATED EVENT. THE CG STATED THE HP HAD TO LEAVE FOR AN EMERGENCY AND UPON RETURN HOME, CONNECTED AGAIN BY MISTAKE WHILE IN PRIME. THE CG STATED THAT THE NURSE WAS AWARE AND THE CG FURTHER CONFIRMED AWARENESS OF PROPER PROCEDURES. THERE WAS NO ADVERSE EVENT RESULTING FROM THIS INCIDENT.

    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 80 YR HOMECHOICE APD SYSTEM/REF (B)(4)