BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2080132 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05572
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 11, 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, AND AS SUCH A DEVICE EVALUATION AND BATCH REVIEW WILL NOT BE CONDUCTED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS DISCARDED, HOWEVER A COMPANION SAMPLE WITH THE SAME LOT NUMBER WAS AVAILABLE AND REQUESTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING A FOLLOW UP FOR AN UNRELATED ALARM, PRODUCT SURVEILLANCE HAD CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011. PRODUCT SURVEILLANCE LEARNED THAT AFTER RECEIVING THE ALARM, THE HP POWER CYCLED AND REUSED THE SAME SUPPLIES TO COMPLETE THE THERAPY. THE NURSE WAS NOT CONTACTED REGARDING THE EVENT, SO BAXTER ADVISED THE PATIENT TO CONTACT THE NURSE. NO PATIENT 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 H11B13055

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR HOMECHOICE