BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1903853 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06063
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SE 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.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 TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 3 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP) AND ASSISTED TO CLEAR THE ALARM. PER THE HP, THERE WERE NO LEAKS OR DISCONNECTS ON THE SETUP. THE HP WOULD COMPLETE THERAPY WITH MANUAL EXCHANGE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1