BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2092033 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06128
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE, THE PRODUCT IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. 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

    THIS IS AN INTERNATIONAL COMPLAINT WHERE THE PATIENT RECEIVED A SYSTEM ERROR (SE) 2240 ALARM. CARE GIVER FOUND ALARMS IN ALARM LOG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED ALARM WITH HIM. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE