BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3200753 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16982
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K123868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE NOTED THAT THE SEPTUM OF THE MIDDLE Y-SITE WAS INVERTED. MICROSCOPIC EXAMINATION OF THE Y-SITE NOTED THAT THE CENTER SPLIT WAS PRESENT, WITH AN OFF-CENTER ENTRY SITE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET HAD BLOOD BACK UP INTO THE TUBING DURING INFUSION. IT WAS NOTED THAT THE SECOND INJECTION PORT FROM THE TOP HAD BEEN ACCESSED, HOWEVER IT DID NOT RESEAL AND A LARGE PORTION OF THE PATIENT'S BED WAS WET. INTERMITTENT AIR BUBBLES WERE ALSO NOTED BETWEEN THE PATIENT AND THE AFFECTED INJECTION PORT. THE DEVICE WAS BEING USED CONCOMITANTLY WITH A COLLEAGUE TRIPLE CHANNEL INFUSION PUMP AND AN INTRAVENOUS (IV) BAG. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO REPORT OF ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297763 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12K23022

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR UNKNOWN IV BAG| COLLEAGUE TRIPLE CHANNEL PUMP