BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUA SEAL CDU

    MDR report key: 185331 · Received September 3, 1998

    Report

    Report Number
    9611018-1998-00015
    Event Type
    Malfunction
    Date Received
    September 3, 1998
    Report Date
    August 7, 1998
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THAT THE PT TUBING DISCONNECTED FROM THE AQUA SEAL CDU AT ITS CONNECTION TO THE COLLECTION RESERVOIR. SHE STATED THAT WHEN THE PT WAS BEING TRANSPORTED FROM THE PACU TO THE SICU SHE LOOKED DOWN AND NOTICED THAT THE PT TUBING (BENEATH THE CORRUGATED MATERIAL) WAS NO LONGER CONNECTED TO THE COLLECTION RESERVOIR ON THE UNIT, AND BLOOD WAS DRIPPING ONTO THE FLOOR. NO PT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA SEAL CDU CHEST DRAINAGE UNIT KDQ SHERWOOD MEDICAL INDUSTRIES NA 97K262T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN