BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET

    MDR report key: 16074866 · Received December 29, 2022

    Report

    Report Number
    1416980-2022-07168
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    November 22, 2022
    Report Date
    April 18, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412565743
    PMA / PMN Number
    K180739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H6 AND H10. H10: THE DEVICES WERE NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DURING FOLLOW UP, ADDITIONAL INFORMATION WAS PROVIDED AND UPDATES WERE MADE TO A1-A6, B5, D1, D4, G4: A1: NONE (PREVIOUSLY SUBMITTED AS UNKNOWN). A2-A6: NA (PREVIOUSLY SUBMITTED AS NI). B5: IT WAS REPORTED THAT THERE WAS A KINK RIGHT BELOW THE DRIP CHAMBER OF A CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SET. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. (PREVIOUSLY SUBMITTED AS IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED ACCESS SET WAS KINKED RIGHT BELOW DRIP CHAMBER. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT). D1: BRAND NAME: CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET (PREVIOUSLY SUBMITTED AS NI). D4: CATALOGUE #: 2R8537 (PREVIOUSLY SUBMITTED AS ASKU). D4: LOT#: R22F29215 (PREVIOUSLY SUBMITTED AS ASKU). D4: UDI#: (01)00085412565743 (PREVIOUSLY SUBMITTED AS NI). G4: PMA/510K # OR BLA # IS K180739 (PREVIOUSLY SUBMITTED AS NI). H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE TUBING WAS FOUND KINKED WITHOUT THE WALLS TOUCHING. PRESSURE AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE PRIMING WAS PERFORMED AT THE SET WITH A BAG OF STERILE WATER AND NO ISSUES WERE OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A KINKED COLLAPSE SET IS AN OBVIOUS DEFECT AND IT IS NOT LIKELY TO IMPACT PATIENT THERAPY. IT IS UNLIKELY TO CAUSE A SERIOUS INJURY IF IT WERE TO RECUR. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED ACCESS SET WAS KINKED RIGHT BELOW DRIP CHAMBER. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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
    2409653 CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R22F29215 00085412565743

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown