BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2141669 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08959
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE NURSE WAS ATTEMPTING TO INJECT CHEMO INTO THE Y-SITE CLOSEST TO THE PATIENT VIA AN UNKNOWN SYRINGE. THE Y-SITE WOULD NOT ACTIVATE ONCE CONNECTED, SO THE NURSE DISCONNECTED IT AND RECONNECTED IT, AND IT STILL WOULD NOT FLOW. SHE THEN CHANGED OUT THE ENTIRE SET AND WAS ABLE TO COMPLETE IT. THE SAMPLE WAS NOT AVAILABLE AS IT WAS DISCARDED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) THAT THE Y-SITE OF THE CLEARLINK NON-DEHP CONTINU-FLO SET DID NOT WORK WHEN THEY TRIED TO ACCESS IT. THE PROCESS STEP IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R11B15100

    Patients

    Seq Age Sex Outcome Treatment
    1