BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1961794 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00657
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 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) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO USER ERROR. THE HP STATED SHE CONNECTED PRIOR TO THE "CONNECT YOURSELF" MESSAGE. THE ALARM WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT WAS CONNECTED BEFORE PRIMING WAS COMPLETE. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP STATED SHE CONNECTED PRIOR TO THE "CONNECT YOURSELF" MESSAGE. THE TSR ASSISTED THE HP TO END THERAPY. THE HP CONFIRMED TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE APD CYLER (B)(4) REFURBISHED