BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1970570 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01005
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 1, 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 FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 1 OF 4. THE HOME PATIENT (HP) STATED THAT SHE DISCONNECTED DURING DWELL 1. THE HP DID NOT PRESS STOP TO PAUSE THERAPY HP THEN RECONNECTED AFTER THE ERROR OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HP WOULD NOTIFY THE NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP, THE HOME PATIENT STATED THAT THEY DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE HOME PATIENT ALSO STATED THEY ARE CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THIS WAS AN ISOLATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HC CYCLER