BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP C-BLOC WITH SAF, 400 X 2-14

    MDR report key: 2427271 · Received January 5, 2012

    Report

    Report Number
    2026095-2011-00456
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 8, 2011
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. PRODUCT PENDING RECEIPT. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED. I-FLOW PROVIDES A "CAUTION" ON ITS DFU WHICH STATES THE FOLLOWING: CAUTIONS: DO NOT UNDER FILL PUMP. UNDER FILLING THE PUMP MAY SIGNIFICANTLY INCREASE THE FLOW RATE. FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE. FILLING THE PUMP GREATER THAN NOMINAL RESULTS IN SLOWER FLOW RATE. TEMPERATURE WILL AFFECT SOLUTION VISCOSITY, RESULTING IN FASTER OR SLOWER FLOW RATE. THE EASYPUMP C-BLOC RA SELECT-A-FLOW HAS BEEN CALIBRATED USING NORMAL SALINE (NS) AS THE DILUENT AND ROOM TEMPERATURE (22 DECREES CELSIUS, 72 DEGREES FAHRENHEIT) AS THE OPERATING ENVIRONMENT, THE SELECT-A-FLOW SHOULD BE WORN OUTSIDE CLOTHING AND KEPT AT ROOM TEMPERATURE.

    Description of Event or Problem · 1

    DRUG/DILUENT: LEVOBUPIVACAINE AND SALINE. FILL VOLUME: 400 ML. FLOW RATE: 6 ML/HR. PROCEDURE: EPIDURAL ANALGESIA AFTER CESAREAN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED IN ABOUT 30-35 HOURS. IT WAS REPORTED THAT THE PT HAD MOTOR BLOCK IN ADDITION TO ANALGESIA. NO ADVERSE REACTION. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP C-BLOC WITH SAF, 400 X 2-14 ELASTOMERIC PUMP MEB I-FLOW, LLC 5001463 142621

    Patients

    Seq Age Sex Outcome Treatment
    1