BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022591 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03311
    Event Type
    Malfunction
    Date Received
    March 17, 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
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM 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).

    Description of Event or Problem · 1

    THE NURSE (RN) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 4 OF 6. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE RN TO CYCLE POWER TO CLEAR ALARM. THE TSR FURTHER ADVISED TO SETUP WITH NEW SUPPLIES. THE RN STATED NOTHING UNUSUAL WAS NOTED WITH THE SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES WITH THE RN. 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 15 YR HOMECHOICE