BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2052203 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04396
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. A 510K NUMBER IS NOT PROVIDED AS THE ACTUAL PRODUCT CODE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR SYSTEM ERROR SE 2267 (FLUID AND AIR IN SET) OCCURRED DURING FILL WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A REGISTERED NURSE (RN) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2367 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FILL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HAD THE RN CYCLE POWER. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT. A FOLLOW UP WAS DONE VIA PHONE. THE RN STATED SHE WAS NOT SURE WHAT CAUSED THE ALARM. THE RN SET THE HOME PATIENT (HP) UP WITH NEW SUPPLIES AND THE HP FINISHED THERAPY.

    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 HOMECHOICE