BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q TUNNELER

    MDR report key: 1790218 · Received August 4, 2010

    Report

    Report Number
    2026095-2010-00083
    Event Type
    Death
    Date Received
    August 4, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K063234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL RPTR. NO SAMPLE WAS AVAILABLE FOR EVAL AND INVESTIGATION. INFO GATHERED DURING THIS INVESTIGATION FOUND THAT THE I-FLOW PRODUCT THAT HAD BEEN USED ON THE PT PRIOR TO DEATH DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. NO DEFECTS WERE IDENTIFIED BY THE CUSTOMER WITH ANY I-FLOW PRODUCT FROM THIS INCIDENT. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A TRAUMA SURGEON REPORTED THAT A PT DIED AFTER HAVING CATHETERS PLACED FOR MULTIPLE RIB FRACTURES. THEY HAD PLACED THE CATHETERS AND GIVEN A BOLUS, BUT HAD NOT HOOKED UP THE PUMP. THE PT HAD HEMOPTYSIS (BLOOD IN AIRWAY) AND WENT INTO CARDIAC ARREST. THEY RESUSCITATED THE PT BUT SHE DIED AT 5 PM, ON (B)(6)2010. THE RISK MANAGER INFORMED I-FLOW THAT THE AUTOPSY ON THE PT SHOWED THAT THE PT DIED FROM BLEEDING SECONDARY TO LUNG CONTUSIONS AS A RESULT OF HER TRAUMA. THE TUNNELER WAS NOT A CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q TUNNELER DISPOSABLE TUNNELER BSO I-FLOW CORP. T17X8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death