BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 13759363 · Received March 14, 2022

    Report

    Report Number
    1416980-2022-01056
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Report Date
    April 18, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    B5: THE AFFECTED PRODUCT IS ¿CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET¿, PREVIOUSLY SUBMITTED AS ¿UNSPECIFIED ACCESS SET¿. D1: BRAND NAME: ¿CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET¿, PREVIOUSLY SUBMITTED AS ¿NI¿. D4: CATALOGUE #: THE CATALOGUE # IS ¿2C8541¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. G4: 510K #: ¿K203609, PREVIOUSLY SUBMITTED AS ¿NI¿. CORRECTION TO G1 INFORMATION. G1: DEVICE MANUFACTURER ADDRESS 1: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED USING THE NAKED EYE WHICH OBSERVED THAT THE MEMBRANE BLUE OF THE CHECK VALVE WAS DAMAGED. THE OTHER COMPONENTS WERE CORRECTLY PLACED AND ACCORDING TO SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED INCLUDING CLEAR PASSAGE AND PRESSURE TESTING AND THE DEVICE PERFORMED ACCORDING TO PRODUCT SPECIFICATIONS. ADDITIONAL BACKFLOW FUNCTIONAL TEST WAS PERFORMED WHICH REVEALED BACKFLOW OF SOLUTION IN THE CHECK VALVE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS RELATED TO THE MATERIAL USED DURING MANUFACTURING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS BACKFLOW INTO AN UNSPECIFIED ACCESS SET. THIS OCCURRED DURING PATIENT INFUSION WITH POTASSIUM PHOSPHATE 30MMOL BOLUS TO RUN OVER SIX HOURS. IT WAS STATED THAT THE NURSE WAS HANGING A BAG ON THE SECONDARY LINE AND WHEN PROGRAMMING THE BAXTER PUMP THEY NOTICED RAPID DRIPPING IN THE CHAMBER WHEN THE PATIENT WAS ONLY TO RUN AT 43 CC/HR. IT WAS FURTHER REPORTED THAT NOTHING WAS INFUSING INTO THE PATIENT BUT THE SECONDARY BAG WAS FLOWING INTO THE PRIMARY BAG. THE INFUSION WAS STOPPED AND THE PATIENT WAS GIVEN A NEW BAG TO COMPLETE THE ELECTROLYTE PROTOCOL. 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
    1989965 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BAXTER PUMP| CLEARLINK SYSTEM SECONDARY MEDICATION SET| POTASSIUM PHOSPHATE