BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q, 400ML, 2-14ML/HR SELECT-A-FLOW PUMP

    MDR report key: 2240886 · Received August 16, 2011

    Report

    Report Number
    2026095-2011-00211
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 18, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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 MFG SPECS PRIOR TO RELEASE. ONE EMPTY PUMP WAS RECEIVED FOR EVAL AND INVESTIGATION. THE VISUAL INSPECTION FOUND THE SELECT-A-FLOW (SAF) SET AT 8ML/HR. THE PINCH CLAMP WAS BROKEN, DISTAL LUER CAP MISSING, AND CATHETER ATTACHED TO THE DISTAL LUER END. THE PUMP WAS REFILLED WITH NORMAL SALINE TO THE NOMINAL FILL VOLUME OF 400ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED WITH THE SAF SET AT 8ML/HR. THE PUMP INFUSED WITHIN SPECS. THE CATHETER WAS INJECTED WITH NORMAL SALINE SOLUTION, AND THE CATHETER PRIMED WITHOUT ANY DIFFICULTY. CUSTOMER COMPLAINT OF FAST FLOW WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 550ML AND FLOW RATE: 8ML/HR. PROCEDURE: ARTHROSCOPIC ROTATOR CUFF REPAIR. CATHPLACE: INTERSCALENE. PUMP EMPTIED IN ABOUT 60 HOURS POST-OP. PT HAD SUDDEN ONSET OF SENSORY AND MOTOR BLOCK. PT HAD SURGERY ON (B)(6) 2011, APPROX 2:30PM. PT SYMPTOMS/SIDE EFFECTS HAVE RESOLVED. PER DFU : LABELED FILL VOLUME: 400ML. MAXIMUM FILL VOLUME: 550ML. SAF FLOW RATE: 2-14ML/HR. DELIVERY ACCURACY: WHEN FILLED TO THE LABELED VOLUME, FLOW ACCURACY IS + OR - 20% OF THE LABELED RATES WHEN INFUSION IS STARTED 0-8 HOURS AFTER FILL AND DELIVERING NORMAL SALINE AS THE DILUENT AT 22 DEGREES CELSIUS/72 DEGREES FAHRENHEIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q, 400ML, 2-14ML/HR SELECT-A-FLOW PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. P400X2-14 132381

    Patients

    Seq Age Sex Outcome Treatment
    1