BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER KIT

    MDR report key: 754463 · Received August 22, 2006

    Report

    Report Number
    2026095-2006-00054
    Event Type
    Other
    Date Received
    August 22, 2006
    Date of Event
    July 21, 2006
    Report Date
    August 14, 2006
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT IS NOT AVAILABLE FOR EVALUATION, THEREFORE, OUR RESULTS AND CONCLUSION ARE BASED ON THE INFORMATION THAT WAS GIVEN TO I-FLOW BY THE INITIAL REPORTER. I-FLOW DID, HOWEVER, TEST THREE (3) RETAIN DEVICES FROM THE SAME LOT OF THE DEVICE INVOLVED IN THIS INCIENT. THE DEVICES WERE FILLED TO THE NOMINAL FILL VOLUME (270 ML) AND THE FLOW RATE ACCURACY TEST WAS PERFORMED AT THE FLOW RATE SETTING THAT WAS SPECIFIED BY THE INITIAL REPORTER (I.E. "7 ML/HR"). THE TEST RESULTS AT THE NOMINAL FILL VOLUME (270 ML) WERE FOUND TO HAVE AN AVERAGE FLOW RATE ACCURACY OF 96.08% (6.73 ML/HR), WHICH IS WITHIN THE NOMINAL LIMITS. EACH DEVICE WAS FOUND TO BE WITHIN LIMITS - THE AVERAGE FLOW RATE DATE FOR EACH PUMP WAS AS FOLLOWS: 92.49% (6.47 ML/HR), 98.16% (6.87 ML/HR) AND 97.59% (6.83 ML/HR). A REVIEW OF THE COMPLAINT LOT HISTORY SHOWED THAT THERE WAS NO OTHER RELATED INCIDENT REPORTED FROM THIS LOT. WE ALSO REVIEWED THE DEVICE HISTORY RECORD OF THIS LOT, WHICH SHOWED THAT THE FLOW RATE ACCURACY TEST WAS CONDUCTED AND FOUND TO BE WITHIN LIMITS. PLEASE NOTE THAT THE FLOW RATE OF THE INFUSION PUMP (ON-Q PAINBUSTER SELECTIVE FLOW) USED IN THIS INCIDENT CAN BE ADJUSTED BETWEEN 1-7 ML/HR. AS REPORTED, THE PATIENT WAS TREATED WITH 0.5%OF BUPIVACAINE AT 7 ML/HR, WHICH WILL DELIVER 840 MG PER DAY AS STATED IN THE ATTACHED TECHNICAL BULLETIN. THIS IS SIGNIFICANTLY HIGHER THAN THE DRUG MANUFACTURER'S RECOMMENDED MAXIMUM DOSAGE, 400 MG PER DAY. THE SURGEON INVOLVED IN THIS INCIDENT INDICATED THAT THE 'PUMP SHOULD HAVE BEEN SET AT 3 - 4 ML/HR.' THEREFORE, THE SELECTION OF THE HIGHER FLOW RATE (7 ML/HR), REPRESENTING DOUBLE THE INTENDED DOSE, COULD HAVE CONTRIBUTED TO THE PATIENT'S SYMPTOMS. IT WAS ALSO REPORTED THAT THE PUMP LEAKED FROM THE CATHETER ENTRY SITE. THE LEAK CAN BE MISTAKEN FOR A FAST FLOW, WHICH WOULD EXPLAIN THE PUMP BEING EMPTY THE FOLLOWING DAY.

    Description of Event or Problem · 1

    POST INGUINAL HERNIA REPAIR, PERFORMED IN 2006, THE PUMP LEAKED ONTO THE PATIENT AND WAS SUSPECTED BY THE DOCTOR OF INFUSING TOO QUICKLY; THE LEAKAGE WAS OCCURRING FROM THE CATHETER ENTRY SITE. THE PATIENT WAS SEEN THE MORNING FOLLOWING HER SURGERY; SHE COMPLAINED OF BEING LIGHT HEADED, HAVING A HEADACHE AND BEING NAUSEOUS. THE FLOW RATE SELECTION WAS SET AT SEVEN (7) - THE PUMP WAS EMPTY WHEN THE PATIENT CAME IN THE FOLLOWING MORNING. THE PATIENT'S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER KIT INFUSION PUMP MEB I-FLOW CORP. SAF01 552760

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other