BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3013228 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06719
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBING WAS BENT JUST UNDER THE VENTED CHAMBER. FUNCTIONAL TESTS REVEALED A RESTRICTED FLOW AND TRACES OF SOLVENT. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT 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 BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN IV SOL ADMINISTRATION SET Y 3V LL HAD BLOCKED TUBING JUST UNDER THE DRIP CHAMBER. THE REPORTED CONDITION OCCURRED DURING PRIMING. THERE IS NO REPORT OF PATIENT INVOLVEMENT, 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
    116291 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12D06V069

    Patients

    Seq Age Sex Outcome Treatment
    1