BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP 400ML, 2-14ML/HR SAF + 5ML/30MIN OD

    MDR report key: 3960677 · Received June 20, 2014

    Report

    Report Number
    2026095-2014-00097
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE IS REPORTED TO BE RETURNING FOR AN ANALYSIS. AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER. THE DISTRIBUTOR HAS REACHED OUT TO THEIR CUSTOMER FOR RETURN OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. PICTURES WERE OBTAINED OF THE SUSPECT DEVICE. RESULTS: RESULTS WILL BE PROVIDED ONCE THE DEVICE IS RECEIVED AND THE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. PER THE DHR REVIEW THE LOT MEET ALL MANUFACTURING SPECIFICATIONS AT RELEASE. CONCLUSIONS: AT THIS TIME I-FLOW IS PENDING THE RETURN OF THE DEVICE FOR AN EVALUATION. THE INVESTIGATION IS ONGOING, ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PHARMACY REPORTED THAT AN ONDEMAND BUTTON WAS STUCK WITH THE YELLOW INDICATOR IN THE BOTTOM POSITION. THIS IS A (B)(6) FEMALE PATIENT WHO UNDERWENT RIGHT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2014. A CB006 PUMP WAS CONNECTED TO AN ADDUCTOR CANNAL NERVE BLOCK CATHETER (PERIFIX EPIDURAL CATH). THE PUMP WORKED FINE UNTIL (B)(6) AROUND 10:45 AM WHEN THE PATIENT PUSHED THE ONDEMAND BUTTON, AND IT STUCK DOWN WITH THE RESERVOIR INDICATOR ON EMPTY. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR SIGNS AND SYMPTOMS OF MEDICATION TOXICITY. THE PATIENT'S CONDITION WAS REPORTED AS STABLE. THE PUMP WAS REPLACED WITH A NEW CB006 PUMP. THIS PUMP'S LOT NUMBER WAS 0200991709 AND WAS FILLED AT 550ML WITH 0.2% ROPIVACAINE. THE SAF RATE WAS SET AT 10ML/HR AND NOT CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362397 ON-Q PUMP 400ML, 2-14ML/HR SAF + 5ML/30MIN OD ELASTOMERIC PUMP MEB I-FLOW, LLC CB006 0200991709

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR DRUG: 0.2% ROPIVACAINE PREFIX EPIDURAL CATHETER