BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183599 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09973
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A CHECK YOUR POSITION ALARM WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS DUE TO USE ERROR, A CLOSED CLAMP ON THE PATIENT LINE DURING PRIMING RESULTING IN AIR IN THE PATIENT LINE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK YOUR POSITION ALARM, WHICH OCCURRED ON THE HOMECHOICE DURING USE DURING FILL 1 OF 5. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT PERFORM TROUBLESHOOTING. THE PATIENT FOUND THAT THE WHITE CLAMP WAS CLOSED ON THE PATIENT LINE. THE PATIENT OPENED THE CLAMP AND PRESSED GO TO START THE FILL. THE TSR ASKED THE PATIENT IF THERE WAS ANY AIR IN THE PATIENT LINE AND AT THAT TIME THE PATIENT STATED NO. THE TSR HAD THE PATIENT PERFORM A MANUAL DRAIN. THE PATIENT STATED IT WAS PULLING AND THEY WANTED TO START THE FILL. THE TSR HAD THE PATIENT PRESS STOP AND CHECK THE PATIENT LINE FOR AIR. THE PATIENT STATED THERE WAS AIR IN THE PATIENT LINE. THE TSR EXPLAINED THE PATIENT NEEDED TO END THERAPY. THE TSR HELPED THE PATIENT END THERAPY AND INSTRUCTED THE PATIENT TO DISCARD THE SUPPLIES AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) ON (B)(6) 2011 REGARDING THE REPORTED EVENT. THE RN STATED THEY WERE NOT MADE AWARE OF THE ALARM AND THAT THE PATIENT WAS CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION WAS AVAILABLE

    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