BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3853687 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18161
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE SECONDARY SET¿S MALE LUER TIP SNAPPED OFF INTO THE PRIMARY SET (NON-BAXTER PRODUCT) WHILE THE SET WAS BEING CHANGED. THE REPORTER STATED THAT NO FORCE WAS BEING USED TO DISCONNECT THE SECONDARY SET FROM THE PRIMARY SET. IT WAS REPORTED THAT THERE WAS ¿SOME LEAKAGE¿ OF POTASSIUM CHLORIDE. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF AN INTERLINK SYSTEM SECONDARY MEDICATION SET BROKE OFF INTO THE CASSETTE OF THE PRIMARY SET. THE DEVICE WAS BEING USED FOR PATIENT INFUSION OF POTASSIUM CHLORIDE IN DEXTROSE. THE SECONDARY SET SNAPPED OFF INTO THE PRIMARY SET WHILE THE SET WAS BEING CHANGED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332848 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY HOSPIRA SET| POTASSIUM CHLORIDE IN DEXTROSE