BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2013389 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02991
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 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 COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2367. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF A SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE. 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.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2367, WHICH OCCURRED ON THE HOMECHOICE (HC), DURING USE DURING THE INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT THE MACHINE BEGAN TO ALARM DURING THE INITIAL DRAIN AND THEY WANTED TO START OVER. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH CYCLING THE MACHINE. THE HC DISPLAYED PRESS GO TO START. THE TSR EXPLAINED TO THE HP THAT BY PRESSING GO, THE MACHINE WOULD ALLOW THE CASSETTE DOOR TO OPEN. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. A FOLLOW UP WAS DONE VIA PHONE. THE HP STATED, THEY STARTED OVER WITH NEW SUPPLIES. THE LOT NUMBER WAS UNKNOWN AND THE SUPPLIES HAD BEEN DISCARDED. THE HP HAS CONTINUED THERAPY. NO INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT.

    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 61 YR HOME CHOICE