BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q C-BLOC WITH SAF

    MDR report key: 2013180 · Received March 7, 2011

    Report

    Report Number
    2026095-2011-00063
    Event Type
    Death
    Date Received
    March 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    I-FLOW CORPORATION
    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

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE DIRECTIONS FOR USE (DFU), ((B)(4)), STATES WARNING: "FLOW RATE IS ADJUSTABLE. TO REDUCE POTENTIAL ADVERSE EFFECTS, MEDICATION DOSING SHOULD BE BASED ON THE MAXIMUM FLOW RATE. THE AMOUNT OF MEDICATION OVER THE THERAPEUTIC PERIOD AND DELIVERY TIME CAN VARY BY AS MUCH AS 20% DUE TO THE FLOW RATE VARIATION. PLEASE TAKE THIS VARIANCE INTO CONSIDERATION WHEN DETERMINING MEDICATION DELIVERY TO REDUCE POTENTIAL ADVERSE EFFECTS. RESULT: THE SAMPLE IS BEING RETAINED BY THE FACILITY AT THIS TIME. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IF ADDITIONAL INFO PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    (PROCEDURE: ELECTIVE PLACEMENT FOR EXTREME PAIN). (CATHPLACE: ANTERIOR TO STERNUM). (DRUG/DILUENT: MARCAINE 0.5%). (FILL VOLUME: UNKNOWN & FLOW RATE: 14ML/HR). TWO PUMPS WERE PLACED SIMULTANEOUSLY FOR THIS PT ((B)(6)). PUMPS WERE PLACED ON PT FOR PAIN MANAGEMENT OF STERNUM. PT CODED AND EXPIRED (DEATH). UPDATE: (B)(6) 2010, DR REPORTED THAT HE USED DIFFERENT PUMPS THAN HE HAD USED IN THE PAST AND WAS UNFAMILIAR WITH THESE PUMPS. HE TYPICALLY USED A DUAL PUMP (2 CATHETERS THAT INFUSE 2ML/HR EACH). DR DID NOT ADJUST THE DIAL ON THE SELECT-A-FLOW (SAF), AND THE DEVICE IS SHIPPED SET AT 14ML/HR. DATE OF EVENT: (B)(6) 2010. PER DFU: LABELED FILL VOLUME: 400ML. MAXIMUM FILL VOLUME: 550ML. THE FLOW RATE: 2, 4, 6, 8, 10, 12, 14ML/HR. WARNING: "FLOW RATE IS ADJUSTABLE. TO REDUCE POTENTIAL ADVERSE EFFECTS, MEDICATION DOSING SHOULD BE BASED ON THE MAXIMUM FLOW RATE. FLOW RATE MAY VARY +/- 20%."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC WITH SAF ELASTOMERIC PUMP MEB I-FLOW CORPORATION CB004 052916

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death