BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1961535 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00624
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    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 BECAUSE THE PATIENT LINE EXTENSION CAME APART. THE HP STATED THAT HER PATIENT LINE EXTENSION WAS NOT CONNECTED CORRECTLY AND CAME APART. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT 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).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE HOME PATIENT (HP) WAS NOT CONNECTED. THE HP STATED THAT HER PATIENT LINE EXTENSION WAS NOT CONNECTED CORRECTLY AND CAME APART. (B)(4) ASSISTED THE HP BY EXPLAINING THE ALARMS AND HAVING THE HP CYCLE POWER 2X TO CLEAR THEM. (B)(4) EXPLAINED THAT THE HP WILL NEED TO START OVER WITH NEW SUPPLIES, OR FINISH UP WITH MANUAL SUPPLIES. THE HP WANTED TO END THERAPY FOR THE NIGHT. (B)(4) ADVISED THE HP TO CALL THE NURSE IN THE NEXT 24 HOURS AND LET HER KNOW WHAT HAPPENED AND INFORM HER OF ANY MISSED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 54 YR HC CYCLER