BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2950188 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03249
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED, WHICH FOUND NO ABNORMALITIES WITH THE SAMPLE. FUNCTIONAL TESTING ON THE DEVICE WAS NOT ABLE TO CONFIRM THE CUSTOMER REPORTED CONDITION. THEREFORE A CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER HEALTHCARE A ONE-LINK VALVE IN WHICH A NO FLOW WAS DETECTED DURING ADMINISTRATION OF PROPOFOL TO A PEDIATRIC PATIENT VIA A CENTRAL LINE WHO WAS BEING SEDATED FOR AN UNSPECIFIED SCAN - EITHER AN MRI OR CT SCAN. THERE IS PATIENT INVOLVEMENT; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54346 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 PROPOFOL, CENTRAL LINE