BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERLINK CATHETER EXTENSION SET

    MDR report key: 529339 · Received June 11, 2004

    Report

    Report Number
    6000001-2004-00966
    Event Type
    Death
    Date Received
    June 11, 2004
    Date of Event
    May 9, 2004
    Report Date
    May 17, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED FROM BAXTER AFFILIATE. THE REPORT STATES THAT THE INTERLINK INJECTION SITE UNITENTIONALLY DISCONNECTED FROM THE FEMALE LUER ADAPTER OF THE Y-TYPE CATHETER EXTENSION SET DURING PT USE. REPORTEDLY, "NO REFLUX BLEEDING APPEARED." REPORTER STATED THAT THE AFFECTED UNIT WAS UNDER THE PT'S PILLOW WHEN THE DISCONNECTION HAPPENED. AS A RESULT, THE REPORTED DISCONNECTION WAS NOT DETECTED IMMEDIATELY. WHEN ASKED, REPORTER STATED THAT CONNECTIONS HAD NOT BEEN CHECKED TO INSURE THAT THE INJECTION SITE WAS FIRMLY ATTACHED TO THE FEMALE LUER. BAXTER REPORTED THAT THE PT DIED, HOWEVER, THE CAUSE OF DEATH IS UNKNOWN. IT WAS REPORTED THAT THE AFFECTED UNIT WAS CONNECTED TO PT'S SUBCLAVIAN DOUBLE LUMEN CENTRAL VENOUS CATHETER. TOTAL PARENTERAL NUTRITION WAS REPORTED TO HAVE INFUSED THROUGH ONE LUMEN. AMRINONE AND DOPAMINE HYDROCHLROIDE WERE REPORTED TO HAVE INFUSED THROUGH THE LUMEN ATTACHED TO THE AFFECTED UNIT. BAXTER REPORTED THAT THE PT WAS HOSPITALIZED SINCE 12/2003 FOR CARDIAC INCOMPETENCE. REPORTEDLY, PT HAD A FEVER FROM INFECTIOUS ENDOCARDITIS. REPORTER STATED THAT PT'S HEALTH CONDITION WAS STABLE AND THAT THE HOSP WAS THINKING OF DISCHARGING THE PT HOME. IT IS THOUGHT THAT THE AFFECTED UNIT WAS CONNECTED TO THE PT IN 5/2004. THREE DAYS LATER AT 16:00 THE NURSE, PERFORMING ROUTINE ASSESSMENT, FOUND NO CHANGES IN PT'S CONDITION AS WELL AS NO ABNORMALIEIS WITH MEDICAL DEVICES. AT 18:00, PT'S BLOOD PRESSURE DROPPED TO 78. PT'S BASELINE BLOOD PRESSURE WAS 100. REPORTER STATED, "THE PUMP WAS CHECKED, BUT LINE WAS NOT." AT 20:00, "BLOOD PRESSURE COULD NOT BE DETECTED." AT THIS TIME, IT WAS NOTED THAT THE INJECTION SITE HAD BEEN DISCONNECTED AND THAT THERE WAS A YELLOW STAIN ON PT'S PILLOW, WHICH WAS IDENTIFIED AS AMRINONE. IT WAS REPORTED THAT NEITHER AMRINONE AND DOPAMINE HYDROCHLORIDE WERE INFUSING. REPORTEDLY, THE PT WAS IN SHOCK CONDITION. THE INJECTION SITE WAS RECONNECTED TO THE FEMALE LUER ADAPTER AND USED FOR INFUSION OF DOPAMINE HYDROCHLORIDE. THE NEXT DAY AT 02:00 PT'S BLOOD PRESSURE RETURNED TO 90 AND SATURATION RECOVERED TO "NORMAL." AT 13:45, PT'S CONDITION SUDDENLY DETERIORATED. REPORTER STATED THAT ALTHOUGH RESUSCITATION THERAPY SUCH AS HEART MASSAGE WAS TRIED, THE PT'S HEART FUNCTION STOPPED. THE PT EXPIRED AT 14:15. THE CAUSE OF DEATH WAS UNKNOWN AND NO AUTOPSY WAS PERFORMED. REPORTER FURTHER STATED THAT THE HOSP COMMENTED THAT THE CAUSE OF PT'S DEATH MIGHT NOT HAVE BEEN DIRECTLY RELATED TO THE REPORTED DISCONNECTION OF THE INJECTION SITE, BECAUSE BLOOD PRESSURE WENT DOWN FOLLOWING THE DISCONNECTION CAUSED INCIDENT, BUT IT RECOVERED AFTER DOPAMINE HCL INFUSION WAS RESTARTED. HOWEVER, THE HOSP THINKS THAT IT MAY HAVE BEEN A FACTOR BECAUSE THE DISCONNECTION CAUSED A DROP IN THE BLOOD PRESSURE OF THE PT WHO HAD BEEN SUFFERING FROM CARDIC INCOMPETENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CATHETER EXTENSION SET EXTENSION SET FOZ BAXTER HEALTHCARE CORP NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death (MFR'S UNK, DATES UNK)| 1. AMRINONE,| 3. HYDROCHLORIDE,| 2. DOPAMINE,| 4. INFUSION PUMP,