BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2485933 · Received March 9, 2012

    Report

    Report Number
    1423500-2012-05908
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 18, 2012
    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). 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 FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A LOW DRAIN VOLUME ALARM WAS CONFIRMED. THE CAUSE WAS AIR IN THE PATIENT LINE. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE/OPEN THE TRANSFER SET 3 TIMES, MOVE THE CLAMP AND RUB THE LINE, PULL UP ON THE LINES, CHECK THE LINES FOR FIBRIN OR AIR AND THERE WAS AIR THROUGHOUT THE LINE. WHEN THE TSR ASKED THE HP IF THEY CHECKED THE PATIENT LINE FOR AIR BEFORE CONNECTING THEY SAID NO. THE TSR EXPLAINED THE IMPORTANCE OF CHECKING THE WHOLE PATIENT LINE FOR AIR BEFORE CONNECTING AND IF THERE WAS AIR THEN TO CALL BACK FOR REPRIME ASSISTANCE. THE TSR ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR WALKED THE HP THROUGH ENDING THERAPY PROCEDURE. THE HP UNDERSTOOD EXPLANATIONS, ENDED THERAPY AND WOULD START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2012, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN). THE RN WAS INFORMED THE HP HAD A LOW DRAIN VOLUME ALARM BECAUSE THERE WAS AIR IN THE LINE. THE RN WAS INFORMED THAT THE HP DID NOT CHECK THE MACHINE TO SEE IF IT WAS FULLY PRIMED. THE RN WOULD RETRAIN THE PATIENT. THE RN STATED THE HP HAS BEEN PERFORMING THERAPY SUCCESSFULLY IN GENERAL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE