BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2202632 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18286
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, THE MDR DOES NOT CONTAIN A US 510K NUMBER.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP ALARMED FOR AN OPEN KEY PRESS. THE PUMP HAD EXPERIENCED AN UPSTREAM OCCLUSION ALARM AFTER ONE MINUTE OR MORE OF DELIVERY PRIOR TO THE OPEN KEY PRESS ALARM. THE OPEN KEY PRESS ALARM INDICATED THAT THE UNKNOWN SET WAS REPLACED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THE UPSTREAM OCCLUSION ALARM HAS BEEN ADDRESSED IN THE RELATED COMPLAINT, THIS COMPLAINT WILL ADDRESS THE POSSIBILITY THAT THE SET IS DEFECTIVE. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED FOR THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1