BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC

    MDR report key: 1053028 · Received May 27, 2008

    Report

    Report Number
    2026095-2008-00064
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SAMPLE HAS NOT BEEN RECEIVED FOR EVAL AND INVESTIGATION, ALTHOUGH REPORTED AS AVAILABLE. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT STATED THAT A PUMP INFUSED TOO FAST, BUT NO FURTHER INFO WAS AVAILABLE. PERTINENT INFO, SUCH AS FILL VOLUME, INFUSION TIMES, FILL TIME, AND PT CONDITION, HAS NOT BEEN RECEIVED, ALTHOUGH REQUESTED. THE DEVICE HISTORY RECORD FOR LOT 7B2792 WAS REVIEWED, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. IN ADDITION, RETAIN SAMPLES FROM LOT 7B2792 WERE TESTED AND FOUND TO FUNCTION WITHIN SPECIFICATION. WHEN ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE PUMP FLOWED TOO FAST. EMPTIED WITHIN 24 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC INFUSION PUMP MEB I-FLOW CORP. CB004 7B2792

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other