BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA TPN

    MDR report key: 6158059 · Received December 9, 2016

    Report

    Report Number
    1416980-2016-18202
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 16, 2016
    Report Date
    January 9, 2017
    Manufacturer
    BAXTER HEALTHCARE - ENGLEWOOD
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION WITH NAKED EYE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION; HOWEVER, UNDER MAGNIFICATION THE BAG WAS FOUND TO CONTAIN A CORNER GOUGE CONSISTENT WITH BEING CAUSED BY FRICTION (DRAGGING THE BAG ON A ROUGH SURFACE OR IMPACT). DURING LEAK TESTING THE LEAK WAS OBSERVED. HOWEVER, THE LEAKS WERE NOT AT THE WELD AND WOULD HAVE BEEN OBVIOUS DURING FILLING. THE MANUAL FILL PORT HAD BEEN USED INDICATING THE DAMAGE OCCURRED AFTER FILLING. THE REPORTED CONDITION OF A LEAK WAS VERIFIED; HOWEVER, THE LEAK WAS NOT FROM THE WELD AS INITIALLY REPORTED BUT RATHER A CORNER GOUGE LOCATED ON THE TOP RIGHT CORNER (GRID LOCATION A38) WITH AN EVA FRAY IMMEDIATELY ADJACENT, INDICATING THE GOUGE WAS CAUSED BY FRICTION (DRAGGING OR IMPACT). THE CAUSE OF THE LEAK WAS DETERMINED TO BE USER ERROR - DAMAGE AFTER FILLING (DRAGGING THE BAG ACROSS A ROUGH SURFACE). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3000 ML EVA TPN BAG WAS LEAKING FROM THE BOTTOM WELD OF THE BAG. THIS OCCURRED BEFORE DISTRIBUTING TO A PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810651 EVA TPN SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - ENGLEWOOD NA 1182094

    Patients

    Seq Age Sex Outcome Treatment
    1