BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2862255 · Received November 29, 2012

    Report

    Report Number
    2026095-2012-00289
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    December 16, 2011
    Report Date
    October 29, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    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. RESULT: THE PUMP COULD NOT BE PRIMED. THE CAUSE WAS ATTRIBUTED TO A PINHOLE LEAK IN THE INNER BLADDER. THE DEVICE FAILURE DIRECTLY CAUSED THE EVENT. THIS INCIDENT OF PINHOLE IN THE INNER BLADDER IS BEING FURTHER INVESTIGATED. (B)(4). ALTERNATE CONTACT: (B)(6). I-FLOW IS FILING THIS REPORT IN RESPONSE TO MEDWATCH UF/IMPORTER REPORT #: (B)(4), (2026095-2012-00289/12/00384 A).

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE. FILL VOLUME: 700ML. FLOW RATE, PROCEDURE, CATHPLACE: NA, PATIENT CONTACT: NO. (REFERENCE 2026095-2012-00291/12-00384 B). WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT THE PUMP (700ML) IS DEFECTIVE. THIS PUMP IS IDENTIFIED AS PUMP #10 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