BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2152335 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08753
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE; THEREFORE, NO EVALUATION COULD BE PERFORMED, AND AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED SYSTEM ERROR 2240 WAS CONFIRMED. THE AS DETERMINED CAUSE IS A USE ERROR - A CLAMP WAS LEFT OPEN ON AN UNUSED SUPPLY LINE. 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).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC), DURING USE DURING DWELL 3 OF 4. THE HOME PATIENT (HP) STATED THEY CYCLED POWER ON THE MACHINE, AND THE HC NOW DISPLAYED PRESS GO TO START. THE HP STATED THEY DISCONNECTED AND REMOVED THE CASSETTE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ADVISED THE HP TO CONTACT THE REGISTERED NURSE (RN). (B)(4) CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SE 2240. THE HP STATED THEY FOUND THAT ONE OF THE LINES HAD NOT BEEN CLAMPED CLOSED AND THAT HAD ALLOWED AIR TO GET INTO THE SYSTEM. THE HP STATED THEY UNDERSTOOD THIS WAS AN ERROR AND THAT THEY WERE AWARE OF THE PROPER PROCEDURE TO SET UP THE SUPPLIES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 58 YR HOMECHOICE CYCLER