BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PAINBUSTER PUMP

    MDR report key: 1784738 · Received July 23, 2010

    Report

    Report Number
    1784738
    Event Type
    Death
    Date Received
    July 23, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 23, 2010
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN FILED A REPORT VIA MEDWATCH REGARDING A BLEED DURING/AFTER CATHETER PLACEMENT WITH AN ON-Q CATHETER TUNNELER. IT WAS INITIALLY BELIEVED THE TUNNELER PERF'D A VASCULAR STRUCTURE CAUSING A HEMOPTISIS, CODE AND EVENTUALLY DEATH. UPON POST-MORTEM EXAMINATION, IT WAS FOUND THAT THE PATIENT DID NOT HAVE A PERFORATED VASCULAR STRUCTURE, BUT HAD BLED FROM A PULMONARY CONTUSION SUSTAINED IN A FALL THAT HAD BROUGHT THE PT TO THE HOSPITAL IN THE FIRST PLACE. THE EVENTS, WHILE CONTEMPORANEOUS, WHERE UNRELATED. THIS REPORT IS TO APPRISE FDA THAT THE INITIAL REPORT THAT IMPLICATES THE ON-Q TUNNELER OF THE PERFORATION WAS PREMATURE AND THE FINDINGS OF THE AUTOPSY EXCULPATES THE TUNNELER AS A CAUSE OF THE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER PUMP PUMP, INFUSION, ELASTOMERIC MEB I-FLOW CORP TUNNELER 024361

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death