BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183635 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09977
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 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 DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE REPORT COULD NOT BE DETERMINED. 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 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 (HC) DURING USE DURING DWELL 4 OF 5. THE PATIENT WAS CONNECTED. THE SE 2240 OCCURRED PRIOR TO THE SE 2367. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED BOTH ALARMS TO THE PATIENT AND ADVISED THE PATIENT TO CLOSE THE CLAMPS AND CYCLE THE POWER ON THE HC TO CLEAR THE ALARMS. THE TSR ADVISED THE PATIENT TO DISCARD THE SUPPLIES AND FINISH WITH MANUALS. THE TSR REVIEWED THE PROPER PROCEDURES PER THE USER MANUAL AND ADVISED THE PATIENT TO MAKE THEIR REGISTERED NURSE (RN) AWARE OF THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT ON (B)(6) 2011 REGARDING THE SE 2240. 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 LINE. THE PATIENT STATED THIS WAS THE FIRST TIME IT HAD EVER HAPPENED AND THEY TALKED TO THEIR RN ABOUT THE ALARM. SINCE THEN THE PATIENT STATED EVERYTHING HAS BEEN GOING FINE. 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 81 YR HOMECHOICE