BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2981564 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04856
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE, NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN TUBING) AND A SYSTEM ERROR 2367 OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 5. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE HOME PATIENT (HP) SAID THAT HE HAD DISCONNECTED IN FILL BECAUSE HE THOUGHT HE WAS NOT FILLING. HE DID NOT USE PROPER DISCONNECT PROCEDURES. HE THEN DISCONNECTED AND RECONNECTED A SUPPLY BAG, AND WHEN HE SAW THAT THE SOLUTION WAS THEN MOVING IN THE PATIENT LINE, THE HP RECONNECTED. THE COMPANY REPRESENTATIVE EXPLAINED THE ALARMS, REVIEWED PROPER PROCEDURES REGARDING DISCONNECT AND ABOUT NOT CONNECTING AND RECONNECTING SOLUTION BAGS. THE HP WAS ADVISED TO LET HIS REGISTERED NURSE KNOW ABOUT THE ALARM. THE PATIENT WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. 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
    84508 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE