BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2626202 · Received June 22, 2012

    Report

    Report Number
    6000001-2012-11839
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    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 DEPARTMENT OF HEALTH AND HUMAN SERVICES SENT NOTIFICATION OF A MEDWATCH TO BAXTER CORPORATE PRODUCT SURVEILLANCE REGARDING A BURETROL SOLUTION SET IN WHICH THE BURETROL CRACKED. ACCORDING TO THE REPORT, THE BURETROL SOLUTION SET WAS CONNECTED TO A (B)(6) PATIENT. THE NURSE CHECK THE PATIENT IV FLUID AT 20:25. THE MEDICATION BEING ADMINISTERED WAS DEXTROSE/NORMAL SALINE AND 20 MEQ POTASSIUM CHLORIDE AT 85CC/HOUR. THE NURSE ATTEMPTED TO SQUEEZE THE BURETROL TO INCREASE THE AMOUNT OF FLUIDS AND THE BURETROL CRACKED. THE FACILITY WAS AWARE THE BURETROL SHOULD NOT BE PUMPED. HOWEVER, THE FACILITY INDICATED THIS IS THE PRACTICE OF THEIR STAFF. THE NURSE IMMEDIATELY CHANGED THE ENTIRE LINE AND THERAPY CONTINUED AS NORMAL. 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 20 YR DEXTROSE| NORMAL SALINE| 20 MILLIEQUIVALENTS POTASSIUM CHLORIDE