BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOC, 400ML, 2-14ML/HR SAF + 5 ML/30MINS

    MDR report key: 3761093 · Received April 10, 2014

    Report

    Report Number
    2026095-2014-00045
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 13, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE IS NOT AVAILABLE FOR AN EVAL AND INVESTIGATION, THEREFORE NO TESTING METHODS WERE PERFORMED. RESULTS: AS A LOT NUMBER COULD NOT BE OBTAINED, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE CONDUCTED. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE TECHNICAL BULLETIN, ON-Q MODELS WITH ON DEMAND BOLUS PROVIDES WARNING INFO REGARDING BOLUS ACTIVATION. CONCLUSION: NO SAMPLE WAS AVAILABLE FOR AN EVAL AND INVESTIGATION. THE SAMPLE WAS DISCARDED. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED, THEREFORE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. PER THE MEDICAL REVIEW THE PT EXPERIENCED A RESPIRATORY CODE WHILE CONNECTED TO THE PAIN MEDICATION PUMP, AND THE PT RECOVERED WITH NARCAN. AS RESPIRATORY DISTRESS IS A POTENTIAL SIDE AFFECT OF THE PAIN MEDICATION, I-FLOW WAS UNABLE TO OBTAIN FURTHER PUMP INFO TO RULE OUT THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.2% ROPIVACAINE. FILL VOLUME: 550ML. FLOW RATE: 6ML/HR. PROCEDURE: RIGHT TOTAL KNEE REMOVAL AND CONVERSION RIGHT TKR. CATHPLACE: RIGHT THIGH - ADDUCTOR CANAL BLOCK. DATE OF SURGERY: (B)(6) 2014. IT WAS REPORTED BY A SALES REP THAT A PUMP WAS ATTACHED TO A PT ON (B)(6) 2014 AFTER SURGERY. IT WAS WORKING WELL IMMEDIATELY AFTER SURGERY AND THEN THE BOLUS BUTTON STOPPED FUNCTIONING 24 HOURS POST-OP. THE BUTTON WOULD NOT STAY DOWN. ADD'L INFO RECEIVED PER THE SALES REP (B)(4) 2014: IT WAS REPORTED THAT IT IS UNK IF THE BOLUS RESERVOIR INDICATOR WAS LOCATED ON THE TOP (FULL) OR THE BOTTOM (EMPTY). THE SAMPLE IS NO LONGER AVAILABLE TO VERIFY RESIDUAL VOLUME, THE PT RECEIVED A NEW PUMP AND THE DEFECTIVE PUMP WAS DISCONNECTED AND DISCARDED. THE LOT NUMBER COULD NOT BE IDENTIFIED. IT WAS ALSO REPORTED THAT THE PT EXPERIENCED AN ADVERSE EVENT UNRELATED TO THE USE OF THE CB006 PUMP. IT WAS REPORTED THAT THE INCIDENT WAS RELATED TO THE OVERUSE OF NARCOTICS AS THE PT RECOVERED AFTER ADMINISTRATION OF NARCAN (AN ANTIDOTE TO NARCOTIC OVERDOSE). THE NURSE PROVIDED THE INCIDENT TIMELINE AS BELOW: (B)(6) 14:55 - INFUSION SET AT 2MLS/HR POST-OP; (B)(6) 15:25 - INFUSION INCREASED TO 6MLS/HR D/T ANTERIOR KNEE PAIN; (B)(6) 15:35 - RESPIRATORY CODE D/T NARCOTICS - IMPROVED WITH NARCAN; INFUSION CLAMPED - PT TAKEN TO ICU AT 16:00; (B)(6) 08:05 - INFUSION RESTARTED AT 2MLS/HR;(B)(6) 10:08 - INFUSION INCREASED TO 4MLS/HR; (B)(6) 11:40 - INFUSION INCREASED TO 6MLS/HR; (B)(6) 16:30 - BOLUS BUTTON FOUND TO BE NOT WORKING PROPERLY; PUMP EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216325 ON-Q C-BLOC, 400ML, 2-14ML/HR SAF + 5 ML/30MINS ELASTOMERIC PUMP MEB I-FLOW LLC CB006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other PENFIX EPIDURAL CATHETER