BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC SAF PUMP

    MDR report key: 1943702 · Received December 15, 2010

    Report

    Report Number
    2026095-2010-00303
    Event Type
    Other
    Date Received
    December 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. IT WAS REPORTED THAT THE PUMP WAS DISCARDED. NO DETERMINATION CAN BE MADE AS TO WHY THE PUMP APPEARED TO INFUSE QUICKLY. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, THE FILE WILL BE REOPENED.

    Description of Event or Problem · 1

    PT HAD FIRST PUMP INFUSE IN 24 HOURS INSTEAD OF 50 HOURS. SHE RECEIVED A SECOND PUMP WHICH INFUSED IN 27 HOURS INSTEAD OF 50 HOURS. SELECT-A-FLOW (SAF) WAS CONFIRMED SECURE AND THE FILL VOLUME WAS CONFIRMED BY THE PHARMACY TO BE 400ML. NO ADVERSE EVENT REPORTED. DATE OF EVENT: UNK. ANP: ASK BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. CB004 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1