BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2488463 · Received March 12, 2012

    Report

    Report Number
    1423500-2012-05998
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    March 4, 2012
    Report Date
    March 4, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS CONFIRMED. THE CAUSE WAS INCOMPLETE PRIME. THE HOME PATIENT (HP) STATED WHEN PRIMING COMPLETED THE PATIENT LINE DID NOT REACH THE TOP AND THE LINE HAD AIR IN IT. THE HP STATED THEY DID NOT KNOW HOW TO REPRIME SO THEY CONNECTED THEMSELVES AND STARTED THE INITIAL DRAIN. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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) STATED WHEN PRIMING COMPLETED, THE PATIENT LINE DID NOT REACH THE TOP AND THE LINE HAD AIR IN IT. THE HP STATED THEY DID NOT KNOW HOW TO REPRIME SO THEY CONNECTED THEMSELVES AND STARTED THE INITIAL DRAIN. THE TSR EXPLAINED TO THE HP IF PATIENT HAD AIR IN THE LINE THEY COULD NOT CONNECT THEMSELVES AND ALSO EXPLAINED TO THE HP HOW TO REPRIME THE PATIENT LINE AND REFERRED THE HP TO THE AT HOME PATIENT GUIDE ON HOW TO REPRIME THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP RECYCLE THE POWER AND SYSTEM ERROR 2367 ALARMED. THE TSR ADVISED THE HP WOULD NEED TO START OVER WITH ALL NEW SUPPLIES. THE TSR HAD THE HP RECYCLE THE POWER AGAIN TO GO TO PRESS GO TO START. PER THE CALLSCRIPT, THE HP WAS CONNECTED AT THE TIME OF THE ALARM, THE PATIENT LINE WAS NOT PROPERLY PRIMED BEFORE CONNECTING, AND THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET CLAMP. PROPER PROCEDURES WERE REVIEWED WITH THE PATIENT. THE PATIENT WOULD COMPLETE THERAPY 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 THAT THE HP DID NOT KNOW HOW TO REPRIME THE PATIENT LINE AND THEY CONNECTED TO THE LINE WHEN THERE WAS AIR IN IT. THE RN WAS REQUESTED TO 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 45 YR HOMECHOICE