BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2031585 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03729
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS AN ALLEGATION AGAINST THE CASSETTE; HOWEVER, SINCE THE EXACT PRODUCT CODE IS UNKNOWN AT THIS TIME, THERE WILL NOT BE A 510K NUMBER PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    THE NURSE (RN) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR (SE) 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SE 2240 INDICATES AIR ENTERED THE SET UP AND FURTHER ADVISED THE RN TO CYCLE POWER ON THE MACHINE TO CLEAR THE ALARM. THE TSR INSTRUCTED THE RN TO START OVER USING NEW SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER USER MANUAL WITH THE RN. THE RN CONFIRMED THERE WERE NO CONNECTION ISSUES AND NOTHING UNUSUAL WAS NOTED WITH THE SET UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1