BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2834198 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05290
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT ISSUE IS CONFIRMED BECAUSE IT WAS REPORTED THAT DURING TROUBLE SHOOTING FOR AN ALARM SITUATION< CHECK LINES AND BAGS, THE CUSTOMER MISTAKENLY SWITCHED JUST A HEATER BAG DURING THERAPY, WHICH IS A USE ERROR/POOR ASEPTIC TECHNIQUE. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4).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 FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING AN ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO ADD A NEW BAG TO AN UNUSED LINE BUT THE HP MISTAKENLY REMOVED THE HEATER BAG AND REPLACED IT WITH A NEW BAG DURING THERAPY ON THE HOMECHOICE (HC). THE TSR ASSISTED THE HP TO END THERAPY AND TO CONTACT THE REGISTERED NURSE (RN) REGARDING THE MISSED THERAPY AND SWITCHING THE BAGS. THERE WAS PATIENT INVOLVEMENT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE