BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY

    MDR report key: 1021992 · Received March 31, 2008

    Report

    Report Number
    1820334-2008-00157
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 3, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    PMA / PMN Number
    K033843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT WITHIN 5 MINUTES OF PLACING THE TRIPLE LUMEN CATHETER, THE CHILD WENT INTO ANAPHYLAXIS SHOCK. THE PATIENT WAS RESUSCITATED. ADDITIONAL INFORMATION PROVIDED 03/07/08, STATED THAT THE PATIENT WAS INTUBATED PRIOR TO LINE INSERTION (RECEIVED FENTANYL, VERSED, VECURONIUM) FOR RSI. TWENTY MINUTES LATER, THE CENTRAL LINE WAS INSERTED WITH NO MEDICATIONS ADMINISTERED (THE LINE WAS FLUSHED WITH SALINE AND HEPARIN PENDING X-RAY FOR PLACEMENT). WITHIN 5-10 MINUTES PATIENT EXPERIENCED CARDIOVASCULAR COLLAPSE/SHOCK. THE CENTRAL LINE WAS REMOVED AND REPLACED WITH A NON-ANTIBIOTIC COATED CATHETER. PATIENT WAS 6 MONTH OLD FEMALE, STABLE PRIOR TO LINE INSERTION, AND AFTER RESUSCITATION CURRENTLY HAS NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY DQO - CENTRAL VENOUS CATHETER DQO COOK, INC. NA 2006325

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other