BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2993201 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05522
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. INITIAL EVALUATION DID NOT CONFIRM THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE UNUSED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS. FUNCTIONAL TESTS WERE PERFORMED, AND NO FAILURES WERE OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT IDENTIFIED. 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 SYSTEM, CONTINU-FLOSET, 2 LUER ACTIVATED VALVES M, WOULD NOT FUNCTION WHEN PIGGYBACKING A NON-BAXTER BLOOD SET INTO THE LOWEST Y PORT OF THE BAXTER SET. THEY REMOVED THE NON-BAXTER BLOOD SET IN ORDER TO SEPARATE THE LINE AND TRIED TO FLUSH AT THE PRIMARY Y SITE WITH A SALINE SYRINGE AND THAT WAS "A NO GO EITHER". THE CONDITION OCCURRED DURING INFUSION. THERE WAS A PATIENT INVOLVED, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96904 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12I08034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BLOOD SET