BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 9604519 · Received January 17, 2020

    Report

    Report Number
    1416980-2020-00071
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Report Date
    February 21, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OVER THE LAST THREE DAYS FROM THE REPORT DATE. PMA/510K # - THE CUSTOMER REPORTED THE SUSPECT CODE WAS EITHER: CLEARLINK SOLUTION SET, CATALOGUE # 2H8486, LOT # R18G04064, PMA/510K # K952074 OR SOLUTION ADMINISTRATION SETS, CATALOGUE # 2H5660, LOT # R17G22133, PMA/510K # K153158. (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : LOT NUMBER R18G04064 WAS MANUFACTURED ON JULY 05, 2018 AND LOT NUMBER R17G22133 WAS MANUFACTURED ON JULY 23, 2017. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS. THE DEVICES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE EVENTS OF UNDERINFUSION OCCURRED WITH UNSPECIFIED ACCESS SETS RUNNING ON A BAXTER PUMP. IT WAS FURTHER REPORTED THERE WAS ABOUT 250ML OF TOTAL PARENTERAL NUTRITION (TPN) LEFT TO INFUSE AT THE END OF THE PROGRAMMED INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63385 SEE H10 SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1