BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP

    MDR report key: 1801920 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02597
    Event Type
    Death
    Date Received
    August 16, 2010
    Date of Event
    October 19, 2009
    Report Date
    July 22, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY'S BIOMED DEPARTMENT WAS CONTACTED AND A BIOMEDICAL TECHNICIAN (BT) CLARIFIED THAT THE PUMP INVOLVED IN THIS EVENT WAS AN ALARIS MEDSYSTEM 3 INFUSION PUMP, NOT A BAXTER PUMP. THE BT DID NOT HAVE ANY FURTHER INFORMATION TO PROVIDE. ALARIS-CAREFUSION HAS BEEN NOTIFIED OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP IS NOT AVAILABLE FOR EVALUATION. AS NEITHER A PRODUCT CODE NOR A VALID BAXTER SERIAL NUMBER IS AVAILABLE, AND BAXTER HAS NOT MANUFACTURED OR DISTRIBUTED AN IVAC PUMP, THE PRODUCT CODE REFLECTED IN THIS SUBMISSION WILL BE UNK_PRD_00003. IF ANY FURTHER CLARIFYING INFORMATION IS OBTAINED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS ERROR 4 MESSAGE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    NOTIFICATION FROM MAUDE ADVERSE EVENT REPORT RECEIVED ON JULY 22, 2010. IT WAS REPORTED THAT IN 2009, A PATIENT STATUS POST CODE BLUE RESUSCITATION WAS MOVED TO SCU. THE FOLLOWING DAY, THE PATIENT WAS RECEIVING AN INTRAVENOUS NEO DRIP VIA AN INFUSION PUMP. THE INFUSION PUMP STALLED (FOR 1-2 MINUTES). THREE LIGHTS ON THE PUMP WERE BEEPING. THE INFUSION PUMP WAS REPLACED. THE PATIENT BECAME BRADYCARDIAC AND WENT IN TO CARDIOPULMONARY ARREST AGAIN AND RESUSCITATION EFFORTS WERE UNSUCCESSFUL. THE INFUSION PUMP WAS CHECKED BY THE BIOMED AND NO MALFUNCTION WAS FOUND. THE NURSE WAS EDUCATED ON USE OF THE PUMP. IT WAS REPORTED THAT THE DETERMINATION WAS MADE THAT THE DEATH OF THIS PATIENT WAS NOT A DIRECT RESULT OF AN EQUIPMENT MALFUNCTION. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER ON 08/12/2010: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6)2009 WITH AN ADMITTING DIAGNOSIS OF ACUTE RESPIRATORY FAILURE. ON (B)(6)2009, THE PATIENT WENT INTO RESPIRATORY ARREST (CODE BLUE) ON THE MEDICAL SURGICAL UNIT AND WAS TRANSFERRED TO THE SPECIAL CARE UNIT (SCU). ON (B)(6)2010, THE PATIENT WAS RECEIVED A NEO DRIP VIA A BAXTER?S IVAC PUMP. THE CUSTOMER INDICATED THAT THE EVENT WITH THE PUMP OCCURRED ON (B)(6)2009 AT 0630. THE CUSTOMER INDICATED THAT THE PUMP WAS REMOVED FROM THE PATIENT AREA AND WAS EVALUATED BY THE BIOMED AND WAS FOUND TO BE WORKING FUNCTIONALLY, AND THE NURSE WAS REEDUCATED ON USE OF THE PUMP. THE CUSTOMER STATED THE PUMP WAS PLACED BACK IN SERVICE AFTER IT WAS DEEMED THAT IT WAS FUNCTIONING PROPERLY AND THERE HAVE BEEN NO OTHER DOCUMENTED FAILURES WITH THIS PUMP. THE CUSTOMER INDICATED THE PUMP IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PUMP, INFUSION FRN UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death