BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP C-BLOC RA PCA AND SAF 2-14ML, 2-14 ML/H

    MDR report key: 3960675 · Received June 20, 2014

    Report

    Report Number
    2026095-2014-00094
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 26, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DISTRIBUTOR HAS RETURNED THE SUSPECT PART TO I-FLOW AND INVESTIGATION IS IN PROGRESS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. VISUAL INSPECTION WAS CONDUCTED DURING RECEIVING. RESULTS: RESULTS WILL BE PROVIDED ONCE THE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. PER THE DHR REVIEW, THE LOT MEETS ALL MANUFACTURING SPECIFICATIONS AT RELEASE. CONCLUSIONS: OUR INVESTIGATION AND EVALUATION IS CURRENTLY IN PROGRESS, ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR REPORTED THAT THE ONDEMAND BOLUS BUTTON OF SIX EASYPUMPS C-BLOC (MODEL 4440008) STAYED AT THE DOWN POSITION WITHOUT MENTIONING WHERE THE YELLOW INDICATOR ON THE DEVICES WERE. THE EVENT WAS DESCRIBED AS "THE BOLUS BUTTON STAYS DOWN WITHOUT JUMPING BACK. THIS INCIDENT PRODUCED A COMPLETE (MOTOR AND SENSITYVE) BLOCK OF THE SHOULDER NERVIUS PLEXUS, VOCAL CORDS PARALYSIS AND HORNER SYNDROME ON THE PATIENT." THE COUNTRY OF INCIDENCE WAS FROM (B)(6) WITH PUMPS FROM LOT 0200999263. A PHOTOGRAPHIC IMAGE WAS PROVIDED BY THE DISTRIBUTOR CAPTURING ALL SIX PUMPS. THE ON-DEMAND BUTTON OF ONE OF THE PUMPS IN THE PHOTOGRAPH APPEARS TO BE IN THE DOWN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362421 EASYPUMP C-BLOC RA PCA AND SAF 2-14ML, 2-14 ML/H ELASTOMERIC PUMP MEB I-FLOW, LLC 4440008 0200999263

    Patients

    Seq Age Sex Outcome Treatment
    1