BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1981966 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01663
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT EXTENSION LINE WAS CONNECTED AFTER PRIMING WAS COMPLETE. THE CARE GIVER (CG) STATED SHE CONNECTED PATIENT LINE EXTENSION AFTER IT PRIMED AND THE AIR IN THE LINE CAUSED THE 2240 ALARM IN I-DRAIN. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240/2367 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING INITIAL DRAIN. THE CARE GIVER (CG) STATED SHE CONNECTED THE PATIENT LINE EXTENSION AFTER THE SET WAS PRIMED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER TO CLEAR THE ALARM, THEN EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE HP FINISH THERAPY VIA MANUAL SUPPLIES AND CONTACT THEIR NURSE. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 PATIENT LINE EXTENSION| HOME CHOICE CYCLER