BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q

    MDR report key: 645870 · Received November 11, 2005

    Report

    Report Number
    2026095-2005-00085
    Event Type
    Death
    Date Received
    November 11, 2005
    Date of Event
    September 15, 2005
    Report Date
    November 9, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COUNTY MEDICAL EXAMINER HAS CONCLUDED THAT THE DRUG, BUPIVICAINE, DELIVERED BY THE I-FLOW INFUSION DEVICE WAS NOT THE CAUSE OF DEATH IN THIS INCIDENT. THE MEDICAL EXAMINER STATED THAT THE CAUSE OF DEATH WAS ATTRIBUTTED TO A HIGH LEVEL OF HYDROCODONE.

    Description of Event or Problem · 1

    AN I-FLOW SALES REP WAS NOTIFIED THAT A PT HAD DIED AT HOME FOLLOWING OUTPATIENT SHOULDER SURGERY. THE PT HAD BEEN USING AN ON~Q PAIN MANAGEMENT SYSTEM POST SURGERY. THE MATTER HAS BEEN REFERRED TO THE LOCAL MEDICAL EXAMINERS OFFICE FOR A DETERMINATION OF THE CAUSE OF DEATH. I-FLOW DOES NOT HAVE SUFFICIENT INFO TO CONDUCT AN INVESTIGATION AT THIS TIME. THE SURGEON INVOLVED HAS EXPRESSED THE OPINION THAT HE DOES NOT BELIEVE THAT THE I-FLOW DEVICE IS A CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q INFUSION PUMP LKK I-FLOW CORP. UNK UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death