BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2495477 · Received March 19, 2012

    Report

    Report Number
    1423500-2012-06550
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 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 COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS CONFIRMED; PER THE COMPLAINT, THE PATIENT REPORTED PRESSING GO PRIOR TO CONNECTING HIMSELF. THE CAUSE WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE), WHICH OCCURRED ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) DID NOT CONNECT THEMSELVES UNTIL AFTER THE ALARM SOUNDED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE AIR IN THE LINE ALARM. THE TSR SAID THAT ALL NEW SUPPLIES WOULD BE NEEDED. THE TSR INFORMED THE HP TO LET THE REGISTERED NURSE (RN) KNOW ABOUT AIR IN THE LINE ALARM. THE TSR HAD THE HP DISCONNECT, THEN CYCLE THE POWER, AND SYSTEM ERROR 2367 OCCURRED. THE HP THEN CYCLED THE POWER AGAIN TO GET BACK TO THE START. PER THE CALLSCRIPT, THE HP WAS NOT CONNECTED AT THE TIME OF THE ALARM, THE HP PRESSED GO ON THE MACHINE PRIOR TO CONNECTING, THE HP DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM, ALL OF THE BAGS WERE SPIKED AND CONNECTED PROPERLY, THERE WAS NO PATIENT EXTENSION LINE USED, THERE WERE NO OPEN CLAMPS ANY UNUSED SUPPLY LINES, AND THERE WAS NOT ANYTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE PROPER PROCEDURE WAS REVIEWED WITH THE HP. THERE WAS THE 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 RN. THE RN WAS INFORMED THAT THE HP PRESSED GO BEFORE CONNECTING ON THE MACHINE, SYSTEM ERROR 2240 OCCURRED, AND THE HP THEN CONNECTED TO THE SETUP. THE RN WAS REQUESTED TO RETRAIN THE HP. 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 66 YR HOMECHOICE