BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1132183 · Received August 19, 2008

    Report

    Report Number
    2026095-2008-00121
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    July 1, 2005
    Report Date
    July 21, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE PRODUCT WAS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, PART NUMBER, LOT NUMBER, OR ACTUAL DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. THE MEDWATCH INDICATED THAT AN ADVERSE EVENT HAD OCCURRED WITH AN OUTCOME OF DISABILITY OR PERMANENT DAMAGE, SO THIS MDR IS BEING FILED. NO CONFIRMATION THAT THE PRODUCT WAS MFG BY I-FLOW WAS PROVIDED. THE REPORT INDICATES THAT MULTIPLE PUMPS MAY HAVE BEEN USED FROM MULTIPLE MANUFACTURERS. IT WAS ALSO REPORTED THAT EPINEPHRINE WAS USED IN THE PUMP. THE DIRECTIONS FOR USE FOR THE PAINBUSTER PUMP CONTAINS A WARNING THAT STATES: "USE OF VASOCONSTRICTORS, SUCH AS EPINEPHRINE OR ADRENALINE, IS NOT NECESSARY AND MAY NOT BE RECOMMENDED FOR CONTINUOUS INFUSIONS." THE ON-Q PUMP DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY" THAT IS AVAILABLE. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON MEDWATCH THAT IN 2005 THERE WAS AN ADVERSE EVENT AND A DISABILITY OR PERMANENT DAMAGE. DATE OF IMPLANT: 2005. UPDATE 2008: IT WAS REPORTED IN 05 THAT A PT HAD A RIGHT ARTHROSCOPIC SLAP TEAR REPAIR. JOINT SURFACES APPEARED NORMAL PER THE SURGEON'S REPORT. STRYKER PAIN PUMP WAS PLACED IN THE RIGHT SHOULDER JOINT WITH 0.5% MARCAINE AT 4 ML/HR WITH AVAILABLE BOLUS EVERY HOUR. IN 2006, THE PT HAD A RIGHT ANTERIOR CAPSULECTOMY WHERE THERE WAS ADHESIVE CAPSULITIS AND CONTRACTURE OF THE RIGHT SHOULDER. A CATHETER WAS PLACED INTO THE SHOULDER JOINT TO BE USED WITH PAINBUSTER TO INSTILL 0.5% MARCAINE AT 2CC/HR FOR 50 HOURS. THE JOINT WAS ALSO INJECTED WITH 30CC OF 0.25% MARCAINE WITH EPINEPHRINE PRIOR TO REMOVAL OF THE CANNULAS. CONTACT ANONYMOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INFUSION PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability WITH EPINEPHRINE| 0.5% MARCAINE| 0.5% MARCAINE