BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2834195 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05289
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT ISSUE IS CONFIRMED BECAUSE IT WAS REPORTED THAT THE CUSTOMER SWITCHED ONLY A SET AND CONTINUED THERAPY WITH REST OF THE DISPOSABLE SINGLE USE SUPPLIES. THE CAUSE WAS UNDETERMINED. BATCH REVIEW RESULTS WERE ACCEPTABLE FOR THE LOT NUMBER H12H01114. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BE CONDUCTED AS THE LOT NUMBER IS AVAILABLE. 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 THE HOME PATIENT (HP) HAD AN ALARM AND HE ONLY CHANGED THE SET DURING THERAPY ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT BAXTER DOES NOT RECOMMEND USING THE SAME SUPPLIES IF HE HAD AN ISSUE WITH THE SUPPLIES. THE TSR HAD THE HP CLOSE THE CLAMPS, DISCONNECT AND CYCLE THE POWER. THE HC ALARMED POWER RESTORED/ FILL 1 OF 4. THE TSR ASSISTED WITH ENDING THE THERAPY AND GETTING THE SET OUT. THE TSR EXPLAINED THE HP COULD START OVER WITH ALL NEW SUPPLIES AND RECOMMENDED THE HP CONTACT THE REGISTERED NURSE (RN) ABOUT USING THE SAME SUPPLIES. 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 CORPORATION H12H01114

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOMECHOICE