BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071970 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05136
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 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 CONFIRMED; 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. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BAXTER'S (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP) AND ASSISTED TO CYCLE POWER THE HC MACHINE. THE HP STATED HE CONNECTS THE PATIENT EXTENSION LINE AFTER THE MACHINE PRIMES. THE TSR EXPLAINED PROPER SET UP OF SUPPLIES ON THE HC. THE HP WOULD RESTART WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. THE REGISTERED NURSE (RN) CONTACTED (B)(4) ON (B)(6) 2011. THE RN STATED THAT THE HOME PATIENT (HP) HAD NOT MADE THEM AWARE OF THE EVENT. (B)(4) EXPLAINED THE ALARM TO THE RN AND THAT THE HP HAD BEEN CONNECTING THE PATIENT EXTENSION LINE AFTER PRIME. THE RN SAID THAT THE HP HAD BEEN TOLD NOT TO DO THIS AND WOULD EXPLAIN TO THE HP THE PROPER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE CYCLER