BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2882482 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07863
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK SECONDARY MEDICATION SET IN WHICH BLOOD WAS OBSERVED TO BE BACKING UP THE TUBING. ACCORDING TO THE REPORT, THE FACILITY RECENTLY CONVERTED FROM USING HOSPIRA SECONDARY SOLUTION SETS TO BAXTER. THE REPORTER INDICATED THAT IT WAS COMMON PRACTICE OF THE FACILITY TO KEEP A SECONDARY MEDICATION SET AT THE PATIENT'S BEDSIDE FOR EMERGENCY SITUATIONS. WHEN THE NURSE ATTEMPTED TO CONNECT A BAXTER SECONDARY SET DIRECTLY TO A PATIENT'S IV ACCESS SITE (AS PREVIOUSLY DONE WITH HOSPIRA), THE NURSE OBSERVED BLOOD BACKFLOW UP THE TUBING. THE MEDICATION BEING ADMINISTERED WAS ALBUMIN. THE REPORTER INDICATED THAT THE FACILITY WAS DIRECTED NOT TO CONNECT SECONDARY MEDICATION SETS DIRECTLY TO IV ACCESS IN THE FUTURE. THE FACILITY NOW KEEPS ALBUMIN SET AT THE PATIENT'S BEDSIDE TO PREVENT FURTHER COMPLICATIONS. THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ALBUMIN