BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLUSET 150X60 W/CAIR CLAMP

    MDR report key: 63376 · Received January 17, 1997

    Report

    Report Number
    1018381-1997-00001
    Event Type
    Injury
    Date Received
    January 17, 1997
    Date of Event
    December 10, 1996
    Report Date
    January 9, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE VALVE REPORTEDLY "DID NOT CLOSE AND ALLOWED A LARGE AMOUNT OF AIR TO INFUSE INTO THE PT." THE DEVICE WAS SET UP IN THE OPERATING ROOM FOR USE DURING A CORONARY ARTERY BYPASS PROCEDURE. THE ANESTHESIOLOGIST PREPARED AND INFUSED A POTASSIUM CHLORIDE PIGGYBACK SOLUTION FROM THE SET THROUGH A 9F INTERNAL JUGULAR INTRODUCER PORT. A THERMODILUTION CATHETER WAS IN PLACE VIA THE INTRODUCER. IT WAS REPORTED THAT "VERY EARLY IN THE CASE, SOMEONE NOTED THE IV SET AND TUBING WERE COMPLETELY DRY AND FILLED WITH AIR." THE PT'S HEART WAS BEING CANNULIZED FOR CARDIOPULMONARY BYPASS CIRCULATION FOR THE SURGERY. THE SURGEON REPORTED "A LARGE AMOUNT OF AIR IN THE RIGHT ATRIUM: THAT WAS EVACUATED WITH CANNULATION/BYPASS. NO PROBLEMS WERE REPORTED DURING PRIMING OF USE OF THE SOLUSET FOR THE POTASSIUM PIGGYBACK. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE EVENT. HE REPORTEDLY HAD A ROUTINE POST-OPERATIVE RECOVERY. HOSPITAL PERSONNEL DESICRIBE THE FLAPPER VALVE AS BEING "TWISTED 180 DEGREES AND PHYSICALLY ADHERED TO THE FLOOR OF THE BURETTE IN A POSITION OFF-SET FROM THE CENTER" OUTLET. NO FURTHER INFO WAS AVAILABLE. SPECIFIC PT INFO WAS CONSIDERED CONFIDENTIAL AND NOT SUPPLIED TO CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUSET 150X60 W/CAIR CLAMP I.V. ADMINISTRATION SET FPA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R