BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1932615 · Received December 19, 2010

    Report

    Report Number
    1423500-2010-07046
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 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). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A CHECK HEATER LINE ALARM. PER THE REPORT INFORMATION, THE CAREGIVER STATED THEY FOUND A SPLIT OR CRACK IN THE HEATER LINE THAT WAS LEAKING FLUID OUT. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION THEREFORE THE REPORT CANNOT BE CONFIRMED IN THE LAB. THE ROOT CAUSE WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK HEATER LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DWELL. THE CG STATED THEY FOUND A SPLIT OR CRACK IN THE HEATER LINE THAT WAS LEAKING FLUID OUT. THE CG WANTED TO START OVER WITH NEW SUPPLIES BUT WAS UNABLE TO REMOVE THE CASSETTE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO CYCLE POWER TO BEGIN ENDING THERAPY. THE CG STATED THE HOME PATIENT (HP) WAS ACTUALLY ABLE TO REMOVE THE CASSETTE AND HAD ALREADY STARTED OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. FOLLOW UP WAS DONE VIA PHONE CALL; THE CG STATED THE HOME PATIENT (HP) HAS STARTED OVER WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED, THE LOT NUMBER WAS UNKNOWN. THE HP HAS SINCE CONTINUED THERAPY WITH NO ISSUES AND NO ADVERSE EVENTS HAVE RESULTED AS A RESULT OF THIS ISSUE.

    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 73 YR PD CYCLER