BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC SAF/PCA

    MDR report key: 2083074 · Received March 31, 2011

    Report

    Report Number
    2026095-2011-00093
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE RECEIVED FOR EVALUATION AND INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. THE DIRECTIONS FOR USE (DFU) (PN 1306085, REV. B) STATES: WARNING: IF THE BUTTON DOES NOT POP BACK UP WITHIN 30 MINUTES, CHECK POSITION OF ORANGE REFILL INDICATOR. IF INDICATOR IS IN THE LOWERMOST POSITION, CLOSE CLAMP. IF BUTTON POPS BACK UP WITHIN 10 MINUTES, OPEN CLAMP AND CONTINUE WITH INFUSION. IF BUTTON REMAINS STUCK, IT MAY RESULT IN A SIGNIFICANT INCREASE IN FLOW RATE TO PATIENT. KEEP CLAMP CLOSED. PUMP SHOULD BE REPLACED IF APPROPRIATE. IF INDICATOR REMAINS IN THE UPPERMOST POSITION, SOMETHING MAY BE IMPEDING THE FLOW. CHECK FOR TUBING KINKS, CLOSED CLAMP OR PATENCY OF CONNECTED DEVICES SUCH AS CATHETER OR UNVENTED FILTER (VERIFY PATENCY) ACCORDING TO YOUR STANDARD PROTOCOL. RESULTS: WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. PROCEDURE: UNK. CATHPLACE: FEMORAL BLOCK. TWO PUMPS HAD BOLUS BUTTON STUCK DOWN. FIRST PUMP WAS ATTACHED TO THE PATIENT AND THE BOLUS BUTTON DID NOT POP BACK UP. PUMP WAS REMOVED. A SECOND PUMP WAS ATTACHED TO THE SAME PATIENT, AND THE SAME ISSUE OCCURRED, AND THE SECOND PUMP WAS REMOVED. CLINICIAN THOUGHT IT MAY HAVE BEEN AN OCCLUSION IN THE CATHETER. NO ADVERSE EVENT REPORTED. DATE OF EVENT: (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF/PCA ELASTOMERIC PUMP MEB I-FLOW CORP. CB006 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1