BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3901559 · Received May 6, 2014

    Report

    Report Number
    2026095-2014-00061
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED TO BE RETURNING FOR AN EVALUATION AND INVESTIGATION BUT AT THIS TIME PENDING RECEIPT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE LOT NUMBER PROVIDED OF THE MANUFACTURED UNIT. RESULTS: THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. EVALUATION AND INVESTIGATION RESULTS WILL BE PROVIDED ONCE TESTING OF THE RETURNED DEVICE IS COMPLETED. 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. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.2% ROPIVACAINE. FILL VOLUME: 550 ML. FLOW RATE: 6 ML/HR. PROCEDURE: TOTAL KNEE REPLACEMENT. CATHPLACE: ADDUCTOR CANAL. DATE OF SURGERY: (B)(6) 2014. IN SUMMARY, A CUSTOMER REPORTED AN INCIDENT THAT OCCURRED TWICE WHILE USING THE ON-DEMAND BOLUS BUTTON. THE PUMP WAS PLACED ON A MALE PATIENT AFTER A TOTAL KNEE REPLACEMENT. THE FIRST INCIDENT OF THE STUCK BUTTON WAS FOUND THE FOLLOWING MORNING ON (B)(6) 2014. THE BUTTON POPPED BACK UP WHILE THE ANESTHESIA TEAM WAS THERE. THE CATHETER WAS FLUSHED, FOUND NO BLOCKAGE AND THE PATIENT RESUMED USING THE DEVICE. THE SECOND INCIDENT OCCURRED WHEN THE PATIENT PRESSED THE BOLUS BUTTON AGAIN AND THE BOLUS BUTTON DID NOT POP BACK UP WITHIN 30 MINS. AT THIS POINT, THE PUMP WAS CLAMPED AND DISCONNECTED FROM THE PATIENT. THE DEVICE IS AVAILABLE FOR RETURN AND PHOTOGRAPHIC IMAGES WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271547 ON-Q C-BLOC: 400ML, 2-14 ML/HR SAF + 5ML/30MIN ELASTOMERIC PUMP MEB I-FLOW LLC CB006 0200991709

    Patients

    Seq Age Sex Outcome Treatment
    1 ANP ARROW CATHETER