BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2220567 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20357
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K905713
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A 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 WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF AN AIR ELIMINATING SPIKE SET IN WHICH A NO FLOW WAS DETECTED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO UR10H09135

    Patients

    Seq Age Sex Outcome Treatment
    1