BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2912086 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00960
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 22, 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
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS CONFIRMED, BASED ON THE CUSTOMER REPORT, AND THE ROOT CAUSE WAS DETERMINED TO BE A USE ERROR DUE TO AN INCOMPLETE CONNECTION. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CONNECTION ISSUE WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE; THE PATIENT WAS NOT CONNECTED. THE CAREGIVER (CG) STATED THEY DID NOT CONNECT THE SUPPLY BAG ALL THE WAY AND IT BECAME SEPARATED DURING PRIME. THE CG WANTED TO KNOW IF THEY WOULD NEED TO SETUP WITH ALL NEW SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE CG THAT IF A BAG WAS CONNECTED AND THEN BECAME SEPARATED, THEY NEED TO START OVER WITH ALL NEW SUPPLIES. THE CG UNDERSTOOD AND WOULD START OVER. THERE WAS PATIENT INVOLVEMENT BUT 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
    18756 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE