BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC: 600ML, 2-14ML/HR SELECT-A-FLOW

    MDR report key: 2862244 · Received November 29, 2012

    Report

    Report Number
    2026095-2012-00284
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 14, 2011
    Report Date
    October 29, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS RETURNED FOR EVALUATION AND INVESTIGATION. A VISUAL EXAMINATION AND FUNCTIONALITY TEST WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR THE LOT NUMBER REPORTED. THE DEVICE LOT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RESULTS: THE PUMP WAS RECEIVED FULL. THE PINCH CLAMP WAS OPENED, TUBING ADJUSTED AND THE PUMP FLOWED. THE PUMP WAS REFILLED WITH SALINE AND WAS FOUND TO FLOW. CONCLUSIONS: THE COMPLAINT WAS NOT CONFIRMED. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. THE PUMP WAS FOUND TO FLOW. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE. ALTERNATE CONTACT: (B)(4). I-FLOW IS FILING THIS REPORT IN RESPONSE TO MEDWATCH UF/IMPORTER REPORT #: (B)(4).

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 700ML. FLOW RATE, PROCEDURE, CATH PLACE: NA. PATIENT CONTACT: NO. WHEN FILLING, FOUND THAT PUMP WOULD NOT PUMP. THIS PUMP IS IDENTIFIED AS PUMP #4 IN MEDWATCH UF/IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC: 600ML, 2-14ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW, LLC CB6004 162866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA