BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3092828 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11302
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED. VISUAL INSPECTION, LEAK TESTING AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO THE SET WITHOUT DIFFICULTY NOTED. THE RETURNED SAMPLE WENT THROUGH UNDER-WATER PRESSURE TESTED AND PERFORMED WITHIN SPECIFICATION. THE EVALUATION OF THE RETURNED SAMPLE COULD NOT DUPLICATE THE ALLEGED ISSUE. AS A RESULT, THE CAUSE COULD NOT BE DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H12J17075 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED. (SAME PATIENT, EVENT AS IN (B)(4) FOR THE TITANIUM ADAPTOR.)

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A CONNECTION ISSUE OCCURRED WHEN A UV FLASH TRANSFER SET WAS BEING CHANGED. THE PATIENT CONNECTOR DID NOT CONNECT WELL WITH THE TITANIUM ADAPTOR. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194251 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12J17075

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER