BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, INFUSION

    MDR report key: 2422371 · Received January 19, 2012

    Report

    Report Number
    6000001-2012-03797
    Event Type
    Death
    Date Received
    January 19, 2012
    Date of Event
    August 6, 2010
    Report Date
    December 21, 2011
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION RECEIVED BY BAXTER'S LEGAL DEPARTMENT INDICATES THAT THE DEVICE INVOLVED IN THIS INCIDENT IS NOT A BAXTER DEVICE. NO FURTHER INVESTIGATION WILL BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL CLINICAL INFORMATION RELATED TO THIS INCIDENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.AS THE PRODUCT CODE IS UNKNOWN, A 510K NUMBER CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    GLOBAL PHARMACOVIGILANCE (GPV) RECEIVED LITIGATION DOCUMENTS WHICH ALLEGE A MANUFACTURING DEFECT AND WRONGFUL DEATH OF THE PATIENT. REPORTEDLY, AN UNKNOWN BAXTER INFUSION PUMP ADMINISTERED AN UNKNOWN MEDICATION AT A DOSE DIFFERENT FROM THE PHYSICIAN'S INTENDED ORDER AND/OR THE DOSAGE SET BY THE NURSE ON THE PUMP. THE PATIENT UNDERWENT BACK SURGERY ON (B)(6), 2010. REPORTEDLY THE PATIENT RECEIVED INTRAVENOUS NARCOTICS POSTOPERATIVELY. REVIEW OF THE LEGAL DOCUMENTS RECEIVED FROM GLOBAL PHARMACOVIGILANCE PROVIDED THE FOLLOWING INFORMATION: THE PATIENT WAS HOSPITALIZED AT THE TIME OF THE EVENT. THE PATIENT REPORTEDLY RECEIVED AN OVERDOSE OF INTRAVENOUS NARCOTICS RESULTING IN POST-OPERATIVE RESPIRATORY INSUFFICIENCY, CARDIOPULMONARY ARREST, AND ANOXIC BRAIN INJURY ON (B)(6), 2010. THE PATIENT EXPIRED ON (B)(6), 2010. CAUSE OF DEATH WAS NOT REPORTED. THE STATUS OF THE DEVICE IS UNKNOWN. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H