BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC: 600ML, 2-14ML/HR SAF

    MDR report key: 3199593 · Received June 27, 2013

    Report

    Report Number
    2026095-2013-00113
    Event Type
    Other
    Date Received
    June 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: IT WAS REPORTED BY THE DIRECTOR OF RISK MANAGEMENT THAT THE DEVICE WILL NOT BE RETURNED FOR AN EVAL AND INVESTIGATION. A DATABASE SEARCH WAS CONDUCTED FROM MAY 2012 - MAY 2013 FOR THE INCIDENT REPORTED IDENTIFYING THAT THE DIAL ON THE SELECT-A-FLOW UNIT WAS MISLEADING. RESULTS: THE RESULTS OF THE SEARCH CONCLUDED THAT THIS REPORTED INCIDENT IS IN FACT THE ONLY COMPLAINT OF THE DIAL TO BE MISLEADING. THERE WERE NO OTHER RELATED INCIDENTS. CONCLUSIONS: THIS INCIDENT WAS DEEMED REPORTABLE AS THE MFR BELIEVES THAT FDA SHOULD BE AWARE OF THE REPORTED INCIDENT THAT IS NOT OTHERWISE COVERED BY DEATH, SERIOUS INJURY, OR MALFUNCTIONS. THE OBSERVED OCCURRENCE HAS BEEN CALCULATING BASED ON THIS ONE COMPLAINT REPORTED OVER AN APPROXIMATE TWO AND A HALF YR PERIOD. (B)(4). INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTED SYSTEM WHICH IS ACTIVELY MONITORED AND TRENDED. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK, FILL VOLUME: UNK, FLOW RATE: UNK, PROCEDURE: UNK, CATHPLACE: UNK. THE RATE DIAL ON THE I-FLOW ON-Q SELECT-A-FLOW PUMP IS MISLEADING. IT IS DIFFICULT TO TELL WHAT THE RATE IS ESPECIALLY IF THE FLOW RATE CHANGE KEY IS LEFT IN PLACE. SEVERAL PEOPLE HAVE LOOKED AT THE RATE DIAL AND THERE WERE SEVERAL DIFFERENT ANSWERS PROVIDED AS TO WHAT THE RATE WAS SET AT. SPECIALLY THERE WAS CONFUSION AS TO WHETHER THE ENDS OF THE RATE CHANGING KEY WERE POINTING TO THE RATE OF FLOW. WE BELIEVE THAT SUCH CONFUSION CAN POSSIBLY LEAD TO INAPPROPRIATE FLOW RATE OF MEDICATION AND HAVE SERIOUS CONSEQUENCES FOR PT'S. WE BELIEVE THE MFR SHOULD LOOK AT THE RATE DIAL AND CHANGE THE DESIGN TO AVOID ANY CONFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292850 ON-Q C-BLOC: 600ML, 2-14ML/HR SAF ELASTOMERIC PUMP MEB I-FLOW, LLC CB6004 0200562006

    Patients

    Seq Age Sex Outcome Treatment
    1