BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1901673 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05897
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 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). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO USER ERROR - INCOMPLETE CONNECTION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING REFILLING THE HEATER IN FILL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP PUSH SPIKE INTO THE SUPPLY BAG AND HALF TWIST. THE HP STATED THAT THE SPIKE MADE A "CLICK" WHEN THEY PUSHED IT INTO THE BAG PORT. THE HC RESTARTED REFILLING. THE HP STATED THAT THE SOLUTION WAS FLOWING INTO THE HEATER BAG THEN. THE TSR HAD THE HP BREAK THE SUPPLY BAG SEAL WITH THE SPIKE TO CLEAR THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. FOLLOW UP WITH THE HOMEPATIENT REVEALED THAT THEY DID NOT PUSH THE SPIKE IN THE BAG COMPLETELY. ONCE SHE WAS ASSISTED OVER THE PHONE SHE WAS ABLE TO CONTINUE WITH THERAPY. THE PATIENT DOES NOT RECALL THE LOT NUMBER OF THE SUPPLIES. THE PATIENT STATED THAT SHE IS DOING WELL WITH HER THERAPY.

    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 69 YR