BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2842086 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05727
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR - REUSE OF SINGLE-USE PRODUCT ISSUE WAS CONFIRMED BECAUSE IT WAS REPORTED THAT THE CUSTOMER SWAPPED A BAG FROM BLUE CLAMP TO THE RED CLAMP LINE, WHICH IS A USE ERROR/POOR ASEPTIC TECHNIQUE. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER IN REFERENCE TO THE USE ERROR; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES THE ISSUE OF USE ERROR- REUSE OF SUPPLIES. A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT. THIS EVENT OCCURRED DURING USE, THE PATIENT WAS CONNECTED, IN FILL 4 OF 4. THERE WAS SOLUTION IN THE BLUE CLAMP BAG ONLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HELPED BYPASS TO DWELL 4 OF 4. PER THE HP, THEY SWAPPED THE BLUE CLAMP TO THE RED CLAMP( USE ERROR). THE TSR EXPLAINED TO HELP THE HP END THERAPY. THE FILL VOLUME (FV) EQUALED 1062 ML. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 HOMECHOICE