BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2183410 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09951
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USER ERROR - FAILED TO FOLLOW THERAPY STEPS THAT OCCURRED DURING DWELL 4 OF 5 WAS NOT CONFIRMED DUE TO LACK OF SAMPLE, AND THE ASSIGNABLE CAUSE WAS DETERMINED TO BE THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET DURING THERAPY. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A 510K NUMBER PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S AFTER HOURS CALL CENTER REGARDING DISCONNECTING HIMSELF FROM THE HOMECHOICE MACHINE DURING DWELL 4 OF 5. THE HP STATED HE HAD A BAD DREAM OR SOMETHING AND DISCONNECTED HIMSELF. THE HP STATED HE WAS IN DWELL 5 OF 5 AND WANTED TO MAKE SURE IT WAS FINE TO CONTINUE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT HE SHOULD HAVE CALLED WHEN HE FIRST DISCONNECTED. THE TSR EXPLAINED PROPER PROCEDURES. THE HP CONFIRMED TO CONTACT THE PERITONEAL DIALYSIS NURSE TO INFORM OF THE INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1