BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO SOLUTION SET

    MDR report key: 12939238 · Received December 6, 2021

    Report

    Report Number
    1416980-2021-07156
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    October 27, 2021
    Report Date
    January 7, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ONE USED SAMPLE OF PRODUCT CODE 2C8537 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ALL COMPONENTS WERE CORRECTLY PLACED AND ACCORDING TO SPECIFICATIONS. A FUNCTIONAL TESTING WAS PERFORMED INCLUDING CLEAR PASSAGE AND PRESSURE TESTING WHICH REVEALED A LEAK IN THE GLAND OF THE THIRD Y-SITE CLEARLINK. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED A MEDWATCH REPORT FOR THIS EVENT: (B)(4). CATALOGUE # - POTENTIAL PRODUCT CODES ARE 2C8537 OR 2R8486. LOT # - A POTENTIAL LOT NUMBER IS R21D13067. MANUFACTURING FACILITY-THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - (B)(4). OR BAXTER HEALTHCARE - (B)(4). PMA/510K # OR BLA # - POTENTIAL 510K NUMBER IS K161808 OR K961225. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS LEAKING FROM THE Y-PORT. THE LEAK WAS OBSERVED 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
    1838121 CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VASOPRESSOR