BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 833284 · Received March 16, 2007

    Report

    Report Number
    2026095-2007-00015
    Event Type
    Malfunction
    Date Received
    March 16, 2007
    Date of Event
    February 23, 2007
    Report Date
    March 8, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE EMPTY AND USED PUMP FOR EVALUATION AND INVESTIGATION. THE PUMP WAS FILLED WITH SALINE SOLUTION TO ITS NOMINAL FILL VOLUME OF 400ML FOR A FLOW RATE PERFORMANCE TEST. THE AVERAGE FLOW RATE WAS FOUND TO BE 4.84 ML/HR, WITHIN THE NOMINAL RANGE (4.25 - 5.75 ML/HR). THE AVERAGE INFUSION TIME WAS 82.64 HOURS, WITHIN THE NOMINAL RANGE (69.57 - 94.12 HOURS NOMINAL RANGE). THE BOLUS DEVICE OPERATION WAS TESTED AND THE REPORTED MALFUNCTION ("STUCK BOLUS BUTTON") COULD NOT BE REPLICATED. IN A PUBLISHED REPORT, CONTINUOUS PERIPHERAL NERVE BLOCKS IN HOSPITAL WARDS AFTER ORTHOPEDIC SURGERY - A MULTI-CENTER PROSPECTIVE ANALYSIS OF THE QUALITY OF POSTOPERATIVE ANALGESIA AND COMPLICATIONS IN 1,416 PATIENTS (ANESTHESIOLOGY 2005; 103:1035-45), SIDE EFFECTS AND RISK FACTORS FOR COMPLICATIONS WITH CONTINUOUS INTERSCALENE BLOCKS, IN REGARDS TO TECHNICAL DIFFICULTIES, WERE OBSERVED BETWEEN 9% AND 44%. THE OVERALL INCIDENCE OF THESE NEUROLOGIC ADVERSE EVENTS IN THE STUDY WAS 6.6% IN THE FIRST TEN DAYS AFTER CONTINUOUS INTERSCALENE BLOCK. THE STUDY ALSO REPORTED THAT OUT OF THE 256 PATIENTS WITHIN THE STUDY THAT HAD INTERSCALENE BLOCK, TWO (2) PATIENTS PRESENTED WITH ACUTE RESPIRATORY FAILURE AND TWO (2) PATIENTS WITH LARYNGEAL AND RECURRENT LARYNGEAL NERVE PARALYSIS. THE STUDY STATED THAT THE TWO (2) PATIENTS COMPLICATED BY RESPIRATORY INSUFFICIENCY (LOWER LOBE COLLAPSE) WERE NOT SURPRISING, AS IPSILATERAL DIAPHRAGMATIC PARALYSIS IS CONSTANT DURING INTERSCALENE BLOCKS AND PERSISTS THROUGHOUT THE INFUSION OF LOCAL ANESTHETICS. IN ADDITION, RESPIRATORY IMPAIRMENT OBSERVED DURING INTERSCALENE BLOCKS HAVE LED TO URGENT REHOSPITALIZATION IN SOME CASES. IN CONCLUSION, THE ADVERSE EVENTS REPORTED (SHORTNESS OF BREATH AND HOARSENESS) IN THIS INCIDENT ARE NOT SURPRISING, ACCORDING TO LITERATURE. SIDE EFFECTS AND RISK FACTORS WITH INTERSCALENE BLOCKS ARE WELL DOCUMENTED RELATIVE TO THE INHERENCY OF THEM. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT AS REQUIRED.

    Description of Event or Problem · 1

    ONE (1) DAY POST RIGHT SHOULDER MUMFORD PROCEDURE, PERFORMED IN 2007, THE PATIENT REPORTEDLY EXPERIENCED SHORTNESS OF BREATH AND HOARSENESS. THE PUMP WAS REPORTED AS INFUSING/EMPTYING EARLIER THAN EXPECTED; THE BOLUS BUTTON ON THIS PARTICULAR PUMP MODEL WAS REPORTED AS BECOMING STUCK IN THE DOWN POSITION, WHICH WAS THE SUSPECTED MALFUNCTION THAT CAUSED THE FAST INFUSION. THE DOCTOR INVOLVED IN THIS INCIDENT REPORTED THE PATIENT AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEA I-FLOW CORP. CB003 664953

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other