BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3041509 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08756
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER LABELING INSTRUCTS THE PATIENT HOW TO PROPERLY TEMPORARILY DISCONNECT. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) AND SYSTEM ERROR 2367 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 4 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) RECYCLED THE POWER AND CLEARED AND EXPLAINED THE ALARMS. THE HC WAS AT "PRESS GO TO START." THE HOME PATIENT (HP) WOULD DISCONNECT AND DISCARD THE SUPPLIES. THE HP STATED THEY WERE TOLD TO DISCONNECT BY THEIR REGISTERED NURSE (RN). THE HAD NOT DISCONNECTED PROPERLY, AND THE HP HAD RECONNECTED. THE HP WOULD CONTACT THEIR RN ABOUT THE ALARM. 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
    142796 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE