BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3082535 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10651
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR (SE) 2240 AND IT WAS DETERMINED TO BE USE ERROR, DUE TO AN OPEN CLAMP. THE LABELING INSTRUCTS THE CUSTOMER TO ENSURE CLAMPS ON UNUSED LINES ARE CLOSED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING A SYSTEM ERROR 2240/2367 (AIR IN LINE) DURING DWELL 2 OF 3 ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HOME PATIENT (HP) HAD AN UNUSED LINE OPEN AND THE HP CYCLED POWER, THEN RECEIVED THE SYSTEM ERROR 2367. THE TSR ASSISTED TO RETRIEVE THE CASSETTE AND ADVISED TO LET THE REGISTERED NURSE (RN) KNOW ABOUT THE ALARM. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR OTHER MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185370 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE