BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2243976 · Received August 24, 2011

    Report

    Report Number
    2026095-2011-00223
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 SPECIFICATION PRIOR TO RELEASE. RESULTS: DEVICE WAS RECEIVED FOR EVAL AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: NAROPIN. FILL VOLUME: 400ML AND FLOW RATE: UNK. PROCEDURE: UNK. CATHPLACE: UNK. PUMP RAN OUT IN 12 HOURS. FILL VOLUME OF PUMP WAS CONFIRMED PRIOR TO FILLING THE PUMP. DATE OF EVENT: (B)(6) 2011. PER DFU: LABELED FILL VOLUME: 400ML. MAXIMUM FILL VOLUME: 550ML. SAF FLOW RATE: 2, 4, 6, 8, 10, 12, 14ML/HR. DELIVERY ACCURACY: WHEN FILLED TO THE LABELED VOLUME, FLOW ACCURACY IS + 20% OF 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 142507

    Patients

    Seq Age Sex Outcome Treatment
    1