BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3010642 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06566
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AVAILABLE SAMPLE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A PHOTOGRAPH OF THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTO REVEALED A CUT IN THE BOTTOM PART OF THE TUBE. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK PUMP/ GRAVITY CONTINFLO SET, 1 VALVE, HAD A FRACTURE IN THE TUBING THAT CAUSED FLUID LEAKAGE. THIS OCCURED WHILE THE DEVICE WAS CONNECTED TO A PATIENT. THE EVENT OCCURRED DURING INFUSION. THERE WAS REPORT OF PATIENT INVOLVEMENT, BUT NO REPORT OF PATIENT INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114310 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12J11V276

    Patients

    Seq Age Sex Outcome Treatment
    1