BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3973488 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25090
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. VISUAL INSPECTION REVEALED THAT THE SET WAS COMPLETELY CUT APART FROM THE TUBING APPROXIMATELY 4CM BELOW THE BLUE SLIDE CLAMP. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SOLUTION ADMINISTRATION SET LINE BROKE IN HALF. THE REPORTER STATED THE SET BROKE WHEN THE NURSE TOOK THE LINE OUT OF A COLLEAGUE INFUSION PUMP. THE DEVICE WAS BEING USED WITH OF 5% DSR, 4ML OF 49.3% MAGNESIUM SULFATE, AND 9ML OF 10% CALCIUM GLUCONATE AT 43ML/HOUR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450753 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 14B01V474

    Patients

    Seq Age Sex Outcome Treatment
    1 COLLEAGUE INFUSION PUMP