BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THOPAZ+ PUMP SALE

    MDR report key: 12337769 · Received August 18, 2021

    Report

    Report Number
    1419937-2021-00065
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    July 19, 2021
    Manufacturer
    MEDELA AG
    Product Code
    BTA
    PMA / PMN Number
    K141553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND WAS EVALUATED ON 10/26/2021. NO ISSUE WERE FOUND WITH THE DEVICE WHEN IT WAS EVALUATED. THE DEVICE PASSED ALL FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A MEDELA SALES REPRESENTATIVE ON (B)(6) 2021, THE CUSTOMER STATED THAT THE DEVICE HAD A LARGE AIR LEAK WHICH SUDDENLY STOPPED, AND THE PATIENT BECAME SYMPTOMATIC. THEY TROUBLESHOT THE UNIT BUT NO EVIDENCE OF BLOCKAGE WAS NOTED. THE UNIT WAS REMOVED FROM THE PATIENT, A STANDARD CHEST TUBE ATRIUM WAS PUT INTO PLACE. THE CHEST X-RAY SHOWED FULL REEXPANSION OF THE LUNG. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER EMAILED MEDELA LLC ACCOUNT MANAGER ALLEGING THAT THEY WERE HAVING PROBLEMS WITH ONE OF THE THOPAZ CHEST DRAINAGE DEVICE WHERE AN AIR LEAK WAS NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233610 THOPAZ+ PUMP SALE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA MEDELA AG 079100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other