BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS

    MDR report key: 13119905 · Received December 30, 2021

    Report

    Report Number
    1416980-2021-07619
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 5, 2021
    Report Date
    February 3, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412565750
    PMA / PMN Number
    K153158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO F10/H6: MEDICAL DEVICE PROBLEM CODES: REPLACED A140501 WITH A050401. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). DEVICE MANUFACTURER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK, NON-DEHP SOLUTION SET LEAKED. IT WAS OBSERVED DURING PATIENT USE. THE TUBING WAS CONNECTED TO A TPN (TOTAL PARENTERAL NUTRITION) BAG AND WAS FOUND TO BE WET RIGHT UNDER THE DRIP CHAMBER. THE DROPS WERE WIPED OFF AND WITHIN 5 MINUTES, THE FLUID HAD RE-ACCUMULATED ON THE TUBING. THE FLUID APPEARED TO BE LEAKING OUT FROM WHERE THE TUBING CONNECTS TO THE DRIP CHAMBER. NEW TUBING WAS USED TO CONTINUE TREATMENT. 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
    2018853 CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R21D07085 00085412565750

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE.| TPN BAG.