BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO SOLUTION SET

    MDR report key: 11287938 · Received February 5, 2021

    Report

    Report Number
    1416980-2021-00436
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    December 28, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO B5, D9, D4, G1, G4, H3 AND H6 B5. THE AFFECTED PRODUCT IS ¿CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET¿, PREVIOUSLY SUBMITTED AS ¿UNSPECIFIED BAXTER SET¿. D1: THE BRAND NAME OF THE AFFECTED PRODUCT IS ¿CLEARLINK CONTINU-FLO SOLUTION SET¿, PREVIOUSLY SUBMITTED AS ¿NI¿. D4: CATALOGUE #: 2C8537, PREVIOUSLY SUBMITTED AS ¿ASKU¿. G1. DEVICE MANUFACTURER ADDRESS: ¿SEE H10¿, PREVIOUSLY SUBMITTED AS ¿NI¿. G1: DEVICE MANUFACTURER STATE: ¿NA¿, PREVIOUSLY SUBMITTED AS ¿NI¿. G4: PMA/510K # OR BLA #: ¿K961225¿, PREVIOUSLY SUBMITTED AS ¿NI¿. G1: MANUFACTURING FACILITY-THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - CARTAGO 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL CARTAGO COSTA RICA 30106 OR BAXTER HEALTHCARE - DOMINICAN REPUBLIC: CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA HAINA SAN CRISTOBAL DOMINICAN REPUBLIC. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED USING THE NAKED EYE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED INCLUDING CLEAR PASSAGE AND PRESSURE TESTING; AND THE DEVICE PERFORMED ACCORDING TO PRODUCT SPECIFICATIONS. NO FLOW WAS NOT OBSERVED IN THE SAMPLE. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BAXTER SET WOULD NOT FLOW WHILE IN USE WITH A SPECTRUM IQ PUMP. IT WAS FURTHER REPORTED THAT THE HEPARIN WAS INFUSING HOWEVER THERE WERE NO DROPS IN THE DRIP CHAMBER. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO 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
    183974 CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 HEPARIN| SPECTRUM IQ PUMP