BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3053551 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09056
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 6, 2013
    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). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR (SE) 2240 AND THE ROOT CAUSE 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 BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN LINE) DURING DWELL 1 OF 4 THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HOME PATIENT (HP) THE TROUBLESHOOTING QUESTIONS AND EXPLAINED THE ALARM. THE HP STATED HE HEARD AIR WHEN HE WAS GOING TO THE BATHROOM BEFORE AND THE DRAIN LINE GOES TO THE BATHROOM. THE TSR EXPLAINED THAT MAY HAVE BEEN AIR FROM THE SOLUTION BAGS BEING PUSH DOWN THE DRAIN LINE. THE TSR HAD THE HP CLOSE THE CLAMPS, DISCONNECT AND CYCLE THE POWER AND THE HC ALARMED SE 2367. THE TSR HAD THE HP CYCLE THE POWER AND THE HC WENT TO PRESS GO TO START. THE TSR ASSISTED WITH GETTING THE SET OUT AND EXPLAINED THE HP WOULD HAVE TO START OVER WITH NEW SUPPLIES OR USE MANUAL BAGS. THE HP ASKED IF HE CAN WAIT UNTIL LATER THAT NIGHT AND THE TSR EXPLAINED THE HP WOULD HAVE TO CONTACT THE REGISTERED NURSE (RN). THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154940 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE