BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171715 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09288
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 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). THE COMPLAINT FOR THE USE ERROR OF CHANGING OUT THE CASSETTE BUT NOT THE BAGS WAS NOT CONFIRMED. THE ROOT CAUSE WAS USE ERROR. 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. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN ALARM, A HOME PATIENT (HP) REVEALED TO GLOBAL TECHNICAL SERVICE (GTS) THAT HE CHANGED OUT THE CASSETTE BUT NOT THE BAGS. GTS ADVISED THE HP TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE SPOKE WITH A NURSE FROM THE HP'S CLINIC, WHO SAID THE HP HAD NOT CONTACTED THE CLINIC WITH ANY PROBLEMS. THE NURSE SAID THEY ADVISE THEIR PATIENTS NOT TO CHANGE ONLY PART OF A SETUP, BUT THAT SHE WOULD LEAVE A MESSAGE FOR THE PRIMARY NURSE TO REVIEW PROPER PROCEDURES WITH THE HP. 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 65 YR HOMECHOICE