BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1903718 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06024
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR (AIR IN LINE) 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM WHICH OCCURRED ON THE HOME CHOICE (HC). THE PROCESS STEP WAS NOT SPECIFIED, AND THE HOME PATIENT (HP) WAS NOT CONNECTED AT THE TIME OF THE CALL. THE NURSE STATED THAT SHE REVIEWED THE ALARM LOG AND FOUND SE 2240. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS TO THE NURSE. THE NURSE WAS UNSURE IF THE PATIENT WAS CONNECTED DURING THE SE 2240 ALARM. THE NURSE WAS TO STRESS TO THE HP TO CALL FOR TECHNICAL ASSISTANCE WHEN ALARMS OCCUR FOR BETTER TROUBLESHOOTING ASSISTANCE. THE SAMPLE WAS DISCARDED. THE HC WAS OPERATIONAL. 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 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1