BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2464284 · Received February 22, 2012

    Report

    Report Number
    6000001-2012-05685
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    (B)(6) SENT NOTIFICATION OF A MEDWATCH TO BAXTER CORPORATE PRODUCT SURVEILLANCE REGARDING AN INTERLINK RETRACTABLE T-CONNECTOR EXTENSION SET IN WHICH THE SEPTUM "POPPED" OFF. ACCORDING TO THE REPORT, THE EXTENSION SET WAS CONNECTED TO AN ARTERIAL LINE OF A (B)(6) MALE PATIENT. DURING ROUTINE SYSTEM CHECK, THE NURSE FLUSHED THE ARTERIAL LINE AT THE ACCESS PORT. IT WAS REPORTED THAT THE SEPTUM OF THE INTERLINK POPPED OFF AND CREATED AN OPENING TO WHAT SHOULD BE A CLOSED AND STERILE LINE OF ACCESS FOR FLUIDS AND ARTERIAL BLOOD PRESSURE (BP) MONITORING. TWO NURSES ATTEMPTED TO EXCHANGE THE FAULTY EXTENSION SET WITH A NEW ONE. HOWEVER, THE ARTERIAL LINE WAS LOST BY THE TIME THE NEW EXTENSION SET HAD BEEN EXCHANGED DUE TO THE FRAGILITY OF LINE PLACEMENT. THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO UNKNOWN ARTERIAL LINE