BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3201710 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17010
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A SYSTEM ERROR 2240, WHERE THE HOME PATIENT INDICATED PROPER DISCONNECTION PROCEDURES WERE NOT USED. DISCONNECTING FROM THE SET IS A USE ERROR THAT MAY CAUSE A SYSTEM ERROR 2240 AND/OR CONTAMINATION. PER HOMECHOICE OPERATOR'S MANUAL, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING DRAIN 1 OF 4, WHILE THE HP WAS CONNECTED. THE HP HAD DISCONNECTED FROM THE HC PRIOR TO THE ALARM WITHOUT USING PROPER ASEPTIC TECHNIQUES AND THEN RECONNECTED ONCE THE HC ALARMED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS. THE TSR ADVISED THE HP TO START THE THERAPY OVER USING ALL NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302400 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE