BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2223677 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11269
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE REPORT COULD NOT BE DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET) AND SE 2367, WHICH OCCURRED ON THE HOMECHOICE PRO DURING USE DURING DWELL 16. THE PATIENT WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS. THE PATIENT HAD THE SE 2240 PRIOR TO THE SE 2367. THE TSR ADVISED THE PATIENT TO CLOSE THE CLAMPS AND CYCLE THE POWER TO CLEAR THE ALARMS. THE TSR REVIEWED THE PROPER PROCEDURES PER THE USER MANUAL WITH THE PATIENT AND SUGGESTED THE PATIENT FINISH THERAPY USING MANUAL 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 PATIENT ON (B)(6) 2011 REGARDING THE REPORTED SE 2240. THE PATIENT STATED THEY WERE ABLE TO RESUME THERAPY SUCCESSFULLY AFTER STARTING OVER WITH NEW SUPPLIES. THE PATIENT STATED THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE SUPPLIES IN USE AND DID NOT KNOW HOW AIR MIGHT HAVE GOT INTO THE LINES. THE PATIENT STATED THEY SPOKE WITH THEIR NURSE ABOUT THE ALARM AND HAS BEEN CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 21 YR HOMECHOICE PRO