BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOC W/DUAL SAF

    MDR report key: 2085541 · Received May 5, 2011

    Report

    Report Number
    2026095-2011-00132
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 12, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. RESULTS: DEVICE WAS RECEIVED FOR EVAL AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. CONCLUSIONS: A F/U REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: ROPIVACAINE 0.2%), (FILL VOLUME: 600ML & FLOW RATE: 4 THEN 5 ML/HR), (PROCEDURE: SPINAL SURGERY), (CATHPLACE: BACK). FAST FLOW. PUMP INFUSED IN 36-40 HOURS INSTEAD OF APPROX 65 HOURS. EACH SAF INITIALLY SET AT 4ML/HR, THEN AFTER 24 HOURS, CHANGED EACH SAF TO 5ML/HR. PT GOT "VERY SICK" ACCORDING TO NURSE, HEART ISSUES. DATE OF EVENT: (B)(6) 2011. PER DFU: LABELED FILL VOLUME: 600ML. MAXIMUM FILL VOLUME: 750ML. SAF FLOW RATE: 1, 2, 3, 4, 5, 6, 7 ML/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 W/DUAL SAF ELASTOMERIC PUMP MEB I-FLOW CORP. CB6007 112155

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other