BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2830559 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04998
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 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). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS SUPPLY FELL AND DISCONNECTED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS (CLB) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL. THE CAREGIVER (CG) STATED THE HOME PATIENT (HP) HAD FOUR BAGS CONNECTED AND ONLY HAD FLUID ON THE FINAL LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THE HP WAS IN FILL 2 OF 5. THE TSR REVIEWED THE PROGRAMMING AND FOUND IT TO BE GOOD. THE CG STATED A BAG BECAME DISCONNECTED EARLIER. THE TSR INFORMED THE CG THAT WAS THE REASON FOR RUNNING SHORT OF SOLUTION. THE TSR ASSISTED THE CG TO END THERAPY AND DISPOSE OF ALL CURRENT SUPPLIES AND START OVER USING ALL NEW SUPPLIES. THE TSR ALSO ADVISED THE CG NOT TO RECONNECT A BAG DURING THERAPY. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S CAREGIVER AND SHE SAID THAT DURING THERAPY THE PATIENT'S BAG ROLLED OFF A TABLE AND ONTO THE GROUND. THAT WAS WHEN THE BAG BECAME DISCONNECTED. SHE HAD ALREADY DISCUSSED WITH THE TSR THE IMPORTANCE OF NOT RECONNECTING A BAG AS IT IS A BREACH IN ASEPTIC TECHNIQUE. SINCE THEN THE PATIENT HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    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 HOME CHOICE