BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1932742 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07059
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT EXTENSION LINE WAS CONNECTED AFTER PRIMING WAS COMPLETE. THE HOME PATIENT STATED THE PATIENT EXTENSION LINES WERE NOT CONNECTED PRIOR TO PRIMING. 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE HP STATED THE PATIENT EXTENSION LINES WERE NOT CONNECTED PRIOR TO PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT AIR HAD ENTERED SETUP. THE TSR INSTRUCTED THE HP TO CYCLE POWER TO CLEAR THE ALARM AND FURTHER ADVISED TO START OVER WITH NEW SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL. THE TSR ADVISED THE HP TO CONNECT THE PATIENT LINE EXTENSION PRIOR TO PRIMING. THE HP CONFIRMED TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2010 (B)(4) SPOKE WITH THE HP'S NURSE WHO STATED THAT THE HP DID NOT DEVELOP ANY ADVERSE EVENT OR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THE HP WAS CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS.

    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 86 YR HOMECHOICE APD CYCLER