BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2173494 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13558
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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. HOWEVER, A BATCH REVIEW WAS PERFORMED AND NO DEVIATIONS WERE NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT ON (B)(6) 2011, A FLO-GARD IV SOLUTION ADMIN SET WAS INVOLVED IN AN AIR IN LINE INCIDENT WITH AN UNIDENTIFIED PATIENT. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT: IV WAS LINE PRIMED- ADMINISTERED THROUGH PUMP. APPROXIMATELY 10 MINUTES LATER, THE PUMP ALARMED AS AIR DRAGGED THROUGH LINE. LINE REMAINED PRIMED FROM IV MED THROUGH TO THE EXIT PORT - LARGE POCKETS OF AIR PRESENT. AIR IN LINE DID NOT REACH THE PATIENT. THE INFUSION WAS STOPPED AND THE INCIDENT WAS LOGGED INTERNALLY. THE PATIENT DID NOT SUFFER ANY CONSEQUENCES. THE CUSTOMER STATES THAT THE BAXTER PUMP ALARMED AS EXPECTED AND THEY HAVE CONTINUED USING IT AT THE UNIT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PUMP