BEUDAMED
    FDA Adverse Event Death Summary report: N

    I-FLOW

    MDR report key: 867199 · Received June 15, 2007

    Report

    Report Number
    2026095-2007-00028
    Event Type
    Death
    Date Received
    June 15, 2007
    Date of Event
    May 11, 2007
    Report Date
    May 21, 2007
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PHYSICIAN INVOLVED IN THIS INCIDENT INDICATED THAT THEY ARE NOT BLAMING THE PUMP AT THIS POINT. THE PUMP INVOLVED IN THIS INCIDENT FUNCTIONED AS DESIGNED. HOWEVER, TOXICOLOGY REPORTS ARE STILL PENDING. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A PATIENT HAD AN ABDOMINOPLASTY, DIED ON THREE DAYS LATER, SEVERAL HOURS AFTER THE PUMP WAS DISCONTINUED. SHE WAS A FEMALE WHO WAS OBESE (100 LBS OVERWEIGHT). SHE CALLED THE SURGEON ON POD 1 WITH A CONCERN THAT THE PUMP WAS NOT INFUSING AND SHE WAS IN PAIN. THEY TOLD HER THAT IT IS DIFFICULT TO TELL IF THE PUMP IS INFUSING. SHE SAW THE SURGEON IN HER OFFICE ON POST OP DAY TWO, AT WHICH TIME, THE PUMP WAS PARTIALLY FULL AND THE PATIENT WAS GETTING PAIN RELIEF. SHE AGAIN SAW THE SURGEON ON POD 3 (THE SAME DAY), AND THE PUMP WAS EMPTY AND THE CATHETERS WERE REMOVED. SHE COMPLAINED OF NAUSEA AND WAS "PALE." THE SURGEON ADVISED HER TO GO TO THE ER, WHICH SHE DID NOT DO. SHE WENT HOME AND WAS APPARENTLY FOUND DEAD SEVERAL HOURS LATER. THE CORONER IS INVESTIGATING THE CASE AND THE PUMP IS AMONG THE THINGS BEING INVESTIGATED. THE PUMP WAS A PM025 AND WAS FILLED WITH BUPIVACAINE 0.5%. THE PATIENT DID NOT HAVE A HISTORY OF CARDIAC DISEASE BUT HAD A CARDIAC CLEARANCE FOR SURGERY. DOSE, FREQUENCY AND ROUTE: 0.5%. THERAPY DATES: THREE DAYS IN 2007. DIAGNOSIS FOR USE: ANAESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW ON-Q PAINBUSTER SOAKER MEB I-FLOW CORPORATION PM025 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death