BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2213338 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10771
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 7, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. 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 AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A ROOT CAUSE COULD NOT BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR 2240 (AIR IN LINE), THIS SYSTEM ERROR OCCURRED DURING INITIAL DRAIN. THE NURSE WAS NOT ABLE TO KEEP SUPPLIES FOR GLOBAL FIELD SURVEILLANCE. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE NURSE TO DISPOSE OF CURRENT SUPPLIES AND START OVER WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER WAS CONTACTED BY THE NURSE ON (B)(6) 2011. THE NURSE STATED THE FOLLOWING: THE CAUSE OF THE ALARM WAS THAT THE TRANSFER SET HAD BECOME SEPARATED FROM THE CATHETER ADAPTER. THE CAUSE OF THE SEPARATION WAS UNKNOWN AND THE NURSE COULD NOT REMEMBER THE PATIENT INVOLVED ONLY THAT IT WAS A FEMALE SO NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE