BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PUMP

    MDR report key: 1961521 · Received January 11, 2011

    Report

    Report Number
    2026095-2011-00336
    Event Type
    Death
    Date Received
    January 11, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    TWO PUMPS WERE PLACED SIMULTANEOUSLY FOR THIS PT. (PUMP MODEL #: PM026-A, CATALOG #: 5001706, LOT #: 082244, DRUG/DILUENT: MARCAINE 0.5%, AND FLOW RATE: 5 ML/HR) AND (PUMP MODEL #: CB004, CATALOG #: 5001481, LOT #: 052916, DRUG/DILUENT: MARCAINE 0.5%, AND FLOW RATE: 2-14 ML/HR). PUMPS WERE PLACED ON PT FOR PAIN MGMT OF STERNUM. PT CODED AND EXPIRED (DEATH). DATE OF EVENT: (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. PM026-A 082244

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death