BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1891929 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05374
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR (B)(4) (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON AN UNUSED SUPPLY LINE. THE HOME PATIENT (HP) HAD 2 BAGS CONNECTED AND LEFT THE UNUSED LINE CLAMPS OPEN. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE HOME PATIENT(HP) CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 4 OF 4. THE HP HAD 2 BAGS CONNECTED AND LEFT THE UNUSED LINE CLAMPS OPEN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CLEAR THE ALARM. THE TSR REVIEWED THE SETUP WITH THE HP. THE TSR THEN REFERRED THE HP TO CALL THE NURSE TO INFORM. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 52 YR