BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2862253 · Received November 29, 2012

    Report

    Report Number
    2026095-2012-00288
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    December 26, 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 A 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: NO LEAKS WERE OBSERVED DURING PRIMING OR PRESSURIZATION. DYE WAS INJECTED AND THE PUMP WAS MONITORED FOR FOUR HOURS AND NO LEAKS WERE OBSERVED AT ANY LOCATION. A 2ND TEST WAS PERFORMED. THE PUMP WAS FILLED WITH SALINE TO 700ML, PRESSURIZED AND MONITORED FOR 17 HOURS. NO LEAKS WERE OBSERVED. CONCLUSIONS: THE COMPLAINT WAS NOT CONFIRMED. THE DEVICE WAS EVALUATED AND THE ALLEGED FAILURE COULD NOT BE DUPLICATED. 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)(6). I-FLOW IS FILING THIS REPORT IN RESPONSE TO MEWATCH UF/IMPORTER REPORT #: 2301300000-2012-8024, (2026095-2012-00288/12-00044D).

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 700ML. FLOW RATE, PROCEDURE, CATH PLACE: NO. PATIENT CONTACT: NO. (REFERENCE: 2026095-2012-00285/00044A, 2026095-2012-00286/12/00044B, 2026095-2012-00287/12-00044C). WHEN FILLING, FOUND THE PUMP HAD LEAKED OUT ALMOST ALL OF ITS CONTENTS INTO THE BAD. PUMP WAS LOCKED AND SET AT "0." THIS PUMP IS IDENTIFIED AS PUMP #12 IN MEDWATCH UF/IMPORTER REPORT #: 2301300000-2012-8024.

    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 142641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA