BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070061 · Received April 26, 2011

    Report

    Report Number
    1423500-2011-05064
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    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 USER ERROR. THE CARE GIVER CHANGED OUT THE CASSETTE ONLY AND REUSED DISPOSABLE SUPPLIES. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. COMPLAINT WAS NOT CONFIRMED. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING PRIME. THE CARE GIVER (CG) STATED THAT THE ALARM CONTINUED SO SHE SWITCHED OUT THE CASSETTE BUT SAVED THE BAGS . THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SETUP AND HAD THE HOME PATIENT (HP) RESTART WITH NEW SUPPLIES. THE CG RESUMED THE PRIME. THE PRIME WAS COMPLETED. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE