BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2982795 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04906
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE EVENT WAS USE ERROR. THERE WAS NO REPORTED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CHECK HEATER LINE ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING FILL 1 OF 4, AND DURING TROUBLESHOOTING A LEAK WAS FOUND. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONFIRMED WITH THE HOME PATIENT (HP) THAT THE FRANGIBLES HAD BEEN BROKEN. THE HP INSPECTED THE DRAIN LINE, MOVED THE RED CLAMP THREE INCHES IN EITHER DIRECTION, AND INSPECTED THE HEATER BAG PORT. THE HP THEN MENTIONED THAT THERE WAS SOME FLUID ON HER NIGHT STAND. THE TSR ASSISTED THE HP WITH ENDING THERAPY DUE TO THE POSSIBLE RISK OF THE SET BEING COMPROMISED. THE TSR ADVISED THE HP TO DISPOSE OF THE CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE HP REGARDING THE EVENT. SHE STATED THAT THE LEAK WAS COMING FROM THE CONNECTION BETWEEN A SUPPLY BAG AND THE CASSETTE. SHE STATED THAT SHE HAD NOT TIGHTENED THE CONNECTION ALL OF THE WAY, AND THERE WERE NO DEFECTS NOTED ON THE SUPPLIES. THERAPY SINCE HAS BEEN GOING WELL, AND THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87574 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE