BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1925302 · Received December 14, 2010

    Report

    Report Number
    1423500-2010-06866
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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). THIS COMPLAINT IS FOR A REPORT OF A CHECK LINES AND BAGS ALARM. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. PER THE COMPLAINT INFORMATION, THE PATIENT THOUGHT THERAPY WAS OVER AND DISCONNECTED BAGS HOWEVER CYCLER ALARM CHECK LINES AND BAGS AND WAS IN FILL. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS USER ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING NEEDING ASSISTANCE ENDING THERAPY ON THE HOME CHOICE (HC) UNIT DURING FILL. THE HP STATED THEY THOUGHT THERAPY WAS FINISHED, CUT THE TUBING AND DISCARDED THE SUPPLIES, NOW THE HC WAS ALARMING CHECK LINES AND BAGS/REFILLING THE HEATER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER AND ASSISTED WITH ENDING THERAPY AND GETTING THE CASSETTE OUT. (B)(4) CONTACTED THE HP REGARDING THE REPORTED PROBLEM. THE HP HAD CONTINUED THERAPY NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    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 55 YR PD CYCLER