BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL- DISPOSABLE

    MDR report key: 1871809 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04473
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE IS UNKNOWN; SHOULD THE PRODUCT CODE BE IDENTIFIED AT A LATER DATE OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 5 OF 7 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) ON THE HOMECHOICE (HC) DURING DWELL 5 OF 7. THE HOME PATIENT (HP) REPORTED HER SUPPLY LINE WAS NOT ALL THE WAY PUSHED INTO THE SUPPLY BAG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP BY HAVING THE POWER CYCLED OFF/ON TO CLEAR ALARM AND EXPLAINED TO START OVER WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1