BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON Q PUMP

    MDR report key: 1961432 · Received December 29, 2010

    Report

    Report Number
    1961432
    Event Type
    Death
    Date Received
    December 29, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 23, 2010
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON-Q PUMP CATHETERS PLACED ON (B)(6)-2010, DUE TO CHRONIC PAIN. SURGEON PLACED FIRST ON Q PUMP CATHETER WITHOUT COMPLICATION. THE SURGEON REQUESTED AN ADDITIONAL ON-Q PUMP AND UPON INSERTION NOTICED THE SECOND CATHETER WAS LONGER THAN THE FIRST CATHETER AND A DIFFERENT MODEL PUMP. THE SECOND MODEL PUMP FLOW HAD A PRESET FLOW RATE BY THE MANUFACTURER. THE SECOND MODEL PUMP FLOW RATE WAS NOT RESET. ADDITIONALLY, THE SURGEON NOTICED THAT THE ANESTHETIC AGENT ((B)(6)) WAS LEAKING. THE LEAKING CATHETER WAS REMOVED, SHORTENED AND REINSERTED. THE SURGERY WAS COMPLETED AND THE PT TRANSFERRED TO RECOVERY AREA IN STABLE CONDITION. APPROXIMATELY 6 HOURS AFTER COMPLETION OF PROCEDURE, PT HAD CHANGE IN CONDITION WHICH CONSISTED OF AGITATION, SEIZURE, RESPIRATORY ARREST, CARDIAC ARREST, AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON Q PUMP ON Q PUMP MEB I-FLOW 082244
    2 ON Q PUMP ON Q PUMP MEB I-FLOW 052916

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death MARCAINE 0.5%, MFR-HOSPIRA, 300ML 5ML/HR| PERINEURAL, (B)(4)-2010| MARCAINE 0.5%, MFR-HOSPIRA, 300ML 14ML/HOUR| PERINEURAL, (B)(4)-2010