BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMPC-BLOC:RA,PCA&SAF 2-14:400ML, 2-14ML/HR

    MDR report key: 3964642 · Received May 30, 2014

    Report

    Report Number
    2026095-2014-00073
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 6, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED NOT TO BE RETURNING FOR AN ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE LOT NUMBER PROVIDED. RESULTS: AS NO DEVICE WAS AVAILABLE FOR AN EVALUATION METHODS WERE NOT PERFORMED; AND RESULTS CANNOT BE OBTAINED. PER THE DHR THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO I-FLOW FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. FLOW MAYBE IMPEDED DUE TO AN OCCLUSION. PATIENT IS NOT RECEIVING INFUSION. BASED ON THE LIMITED INFORMATION THAT HAS BEEN PROVIDED BY THE REPORTER WE ARE UNABLE TO DETERMINE IF THERE WAS PATIENT USE AND THE POSITION OF THE ORANGE INDICATOR. IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. 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

    FILL VOLUME: 400 ML. FLOW RATE: N/A. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. (PLEASE REFERENCE 2026095-2014-00072/(B)(4) AND 2026095-2014-00074/(B)(4)). A DISTRIBUTOR REPORTED THAT THERE WERE THREE PCA BUTTONS NOT WORKING PROPERLY THEY ARE UNABLE TO FILL THE BOLUS CHAMBER AS THE BUTTON WOULD NOT POP BACK UP. 2026095-2014-00073/(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320003 EASYPUMPC-BLOC:RA,PCA&SAF 2-14:400ML, 2-14ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 4440008 0200999263

    Patients

    Seq Age Sex Outcome Treatment
    1