BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2781350 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02056
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 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). ADDITIONAL INFORMATION: THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE. THE ASSIGNABLE CAUSE CODE COULD NOT BE DETERMINED. 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. THE LOT NUMBER IS UNKNOWN. 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- BREACH IN ASEPTIC TECHNIQUE. DURING TROUBLESHOOTING FOR CHECK LINES AND BAGS ALARM, WHILE ON HOME CHOICE (HC) DEVICE DURING USE, DURING FILL, THE CARE GIVER(CG) STATED SHE NEVER CLOSED THE CLAMP ON THE UNUSED LINE. THE CG WAS NOT ABLE TO TELL IF THERE WAS AIR IN THE LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ABOUT CLOSING THE CLAP ON UNUSED LINE. AT THAT POINT, THE CG STATED THAT MAYBE IT WAS. THE TSR ADVISED TO INFORM THE REGISTERED NURSE(RN) REGARDING THIS EVENT AND ENDING THERAPY EARLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 84 YR HOMECHOICE