BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SOLUTION SET

    MDR report key: 9599150 · Received January 16, 2020

    Report

    Report Number
    1416980-2020-00061
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 19, 2019
    Report Date
    February 24, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K952074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: UPDATE BRAND NAME (REMOVE CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET), UPDATE CATALOGUE # (REMOVE 2C8541), ADD LOT # (INITIALLY UNKNOWN), UPDATE PMA/510K # (REMOVE K961225), THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE PACKAGE WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH REVEALED A DIFFERENT PRODUCT CODE THAN INITIALLY REPORTED AND CONTAINED A LOT NUMBER (INITIALLY UNKNOWN). A VISUAL INSPECTION WAS PERFORMED TO THE PICTURE USING THE NAKED EYE, HOWEVER, IT WAS NOT POSSIBLE TO IDENTIFY THE REPORTED ISSUE VIA THE PHOTOGRAPH. DUE TO THE NATURE OF THE SAMPLE NO FUNCTIONAL TESTING COULD BE PERFORMED. THE REPORTED CONDITION WAS NOT VERIFIED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS UNDERINFUSED DURING A CHEMOTHERAPY TREATMENT WITH AN INFUSION PUMP AND A CLOSED SYSTEM DRUG TRANSFER DEVICE (NON-BAXTER). IT WAS FURTHER REPORTED THAT IT SEEMED TO BE TAKING AN EXCESSIVELY LONG TIME TO INFUSE THE 30 MINUTE INFUSION. THE MEDICATION WAS MIXED IN 600 ML AND WAS TO RUN AT 300 MLS/HOUR AND IT TOOK TWO HOURS AND 50 MINUTES TO COMPLETELY INFUSE THE WHOLE BAG. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. 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
    59207 CLEARLINK SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R18G04064

    Patients

    Seq Age Sex Outcome Treatment
    1