BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 15174519 · Received August 5, 2022

    Report

    Report Number
    1416980-2022-04064
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Report Date
    August 30, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H3, H6 AND H10. H10: ONE ACTUAL AND ONE COMPANION SAMPLE WERE RECEIVED FOR EVALUATION (WITHOUT POUCHES). VISUAL INSPECTION WAS PERFORMED USING THE NAKED EYE WHICH DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. UNDER WATER PRESSURE TESTING WAS PERFORMED IN ALL SAMPLES AND NO LEAK OR BLOCKAGE WAS OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H6: REMOVE A140501 FOR BACKFLOW AND ADD A141401. H10: UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE REPORTED ISSUE WAS FAILURE TO PRIME AND THERE IS NO POTENTIAL FOR HARM TO THE PATIENT IN THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SECONDARY MEDICATION SET HAD BACKFLOW ISSUES. THESE ISSUES WERE FURTHER DESCRIBED AS, ¿CHALLENGES RELATED TO THE INABILITY OF THE PRIMARY SOLUTION TO FLOW FREELY (OR AT ALL) INTO THE SECONDARY SET¿. THE ISSUE WAS IDENTIFIED WHILE PRIMING THE DEVICES. 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
    1706826 UNKNOWN SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown