BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELDINGER CENTRAL VENOUS CATHETER

    MDR report key: 311672 · Received January 8, 2001

    Report

    Report Number
    8020616-2000-00006
    Event Type
    Injury
    Date Received
    January 8, 2001
    Report Date
    December 28, 2000
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BEFORE THE EVENT, THE DEVICE WAS USED WITH RIGHT FEMORAL APPROACH WITH THE POSITIONING OF THE TIP OF THE CATHETER ON JUNCTION INFERIOR CAVE VEIN AND RIGHT ATRIUM. CREATION OF STERILE FIELD WITH PREPARATION OF THE SITE WITH AN ANTISEPTIC SOLUTION NEOMEDIL (CO: FARMEC - COMPOSITION: 2.5% BZC, ALCOHOL ETHYLIC 95 DEGREES, OTHER EXCIPIENTS). DURING THE INSERTION THE CATHETER WAS EXTERNALLY WET WITH SALINE SOLUTION IN ORDER TO ACTIVATE THE HYDROMER FOR A BETTER INSERTION. THE INSIDE LUMEN OF THE CATHETER WAS NOT FLUSHED BEFORE THE INSERTION TO PT. OTHER DEVICES USED DURING EVENT: IV CATHETER FOR PERIPHERAL VEIN (BD VENFLON), ENDOTRACHEAL TUBE (MALLINCKRODT), ELECTRODES FOR ECG MONITORING (RED DOT - 3M), RADIOLUS NASOGASTRIC (PORTEX) AND PLASTER FOR MONITORING WITH SATURIMETER INSTRUMENTS, 10ML PLASTIC SYRINGE (ARTSANA) AND 10ML SALINE SOLUTION (SODIUM CHLORIDE 0.9% - FRESENIUS KABI). DEVICE WAS USED FOR 1 MIN ON PT BEFORE THE REACTION WAS SEEN. REACTION WAS SEEN IMMEDIATELY AFTER 1-1.5 MINS THE ANAESTHETIST OBSERVED AN INCREASE OF ENDOTRACHEAL PRESSURE, RUSH CUTNEOUS BEFORE ON THE FACE AND AFTER DIFFUSED ON ALL THE BODY OF THE PT, SERIOUS STATE OF ANAPHYLACTIC SHOCK AND METABOLIC ACIDOSIS. THE USER IMMEDIATELY ADMINISTERED CORTISONE AND THEY PERFROMED A MANUAL VENTILATION, WITH FILLING OF PLASMA EXPANDERS, INFUSION OF DOPAMINE AND COGLUNATE - IN THIS CASE, DR ADMINISTERED THROUGH THE CATHETER: STEROIDS (BETELAN 1.5MMG/1ML)-FLEBOCORTID 100MMG-PLASMA EXPANDERS-D0PAMINE-CALCIUM COGLUNATO, SODIUM BOCARBONATE, T.H.A.M., ALKALIZER SOLUTION. THE ANAESTHETIST PERFORMED TO THE PT ALSO MANUAL VENTILATION F1O2=1 (100% OXYGEN). AFTER 20 MINS THE ACUTE EVENT DISAPPEARED AND THE STATE OF THE PT RECOVERED TO BE NORMAL. THE CATHETER WAS NOT REMOVED IMMEDIATELY WHEN THE REACTION WAS OBSERVED. THE PERMANENCE OF THE CATHETER WAS OF 72 HOURS.

    Description of Event or Problem · 1

    THE USER HAD 2 ANAPHYLACTIC SHOCKS DURING A GENERAL ANESTHESIA AFTER THE INSERTION OF CVC HYDROCATH WITH 2 PEDIATRIC PTS. THESE 2 EVENTS HAPPENED IN OPERATING THEATRE OF NEUROSURGERY IMMEDIATELY AFTER THE POSITIONING OF HYDROCATH. THE 2 PEDIATRIC PTS RECEIVED GENERAL ANESTHESIA. NO PROBLEM WITH THE INDUCTION OF THE GENERAL ANESTHESIA WITH MIDAZOLAM, FENTANEST, PACURONIO, FORANE, N2O/O2, MECHANICAL VENTILATION WITH PREVIOUS INTUBATION ORO-TRACHEAL. AFTER 20 MINUTES FROM INDUCTION OF THE GENERAL ANESTHESIA, AFTER THE POSITIONING OF THE CVC HYDROCATH (WITHOUT ANY PROBLEM) THE USER INJECTED A SALINE SOLUTION FOR FLUSHING THE CATHETER. AFTER THIS THE USER OBSERVED IN INCREASE OF ENDOTRACHEAL PRESSURE AND THE APPEARANCE OF DIFFUSED CUTANEOUS RUSH IN ALL THE BODY OF THE PT AND STATE OF SHOCK. THE USER IMMEDIATELY ADMINISTERED CORTISONE AND HE PERFORMED A MANUAL VENTILATION, WITH FILING OF PLASMA EXPANDERS, INFUSION OF DOPAMINA AND COGLUNATO. AFTER 10-15 MINUTES THE PT HAD AN ACCEPTABLE HEMODYNAMIC SITUATION AND THE DISAPPEARING OF THE CUTANEOUS RUSH. WHEN THE PT WERE STABILIZED THE SURGEON MADE THE INTERVENTION WITHOUT MORE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735 SELDINGER CENTRAL VENOUS CATHETER CENTRAL VENOUS CATHETER FOZ BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. HYDROCATH ONE LUMEN 908199

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention