BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP C-BLOC: 400ML, 5ML/HR + 5ML / 60 MIN

    MDR report key: 3960473 · Received June 9, 2014

    Report

    Report Number
    2026095-2014-00082
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 15, 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 NOT AVAILABLE TO BE RETURNED FOR AN ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. RESULTS: AS THE DEVICE WAS UNAVAILABLE FOR AN EVALUATION TESTING METHODS WERE NOT PERFORMED; THEREFORE RESULTS COULD NOT BE OBTAINED. PER THE DHR REVIEW 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. AS THE DEVICE WAS UNAVAILABLE FOR ANALYSIS, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. IT IS UNKNOWN IF THE ORANGE INDICATOR WAS LOCATED IN THE UPPER MOST POSITION OR THE LOWER MOST POSITION. PER THE DIRECTIONS FOR USE (DFU) PROVIDE THE INSTRUCTIONS AND WARNINGS REGARDING BOLUS ACTIVATION, WARNING, IF THE BOLUS BUTTON WILL NOT LATCH, CLOSE THE CLAMP. CONTINUOUS MEDICATION DELIVERY MAY BE OCCURRING. THIS DELIVERY MAY BE SIGNIFICANTLY GREATER THAN THE TOTAL FLOW RATE. OLE: IT IS NORMAL THAT IT WILL NOT LATCH WITHIN 30 MINUTES OF PRESSING THE BOLUS BUTTON. IF THE ON-DEMAND BUTTON DOES NOT POP BACK UP WITHIN 30 MINS, CHECK THE POSITION OR THE ORANGE INDICATOR: IF THE ORANGE INDICATOR IS IN THE BOTTOM POSITION, CLOSE THE CLAMP. CONTINUOUS MEDICATION DELIVERY MAY BE OCCURRING WHICH CAN BE SIGNIFICANTLY GREATER THAN THE TOTAL FLOW RATE; OR IF THE ORANGE INDICATOR IS IN THE TOP POSITION, SOMETHING MAY BE IMPEDING THE FLOW. CHECK FOR TUBING KINKS, CLOSED CLAMP OR PATENCY OF CONNECTED DEVICES SUCH AS CATHETER OR UNVENTED FILTER (VERIFY PATENCY) ACCORDING TO YOUR STANDARD PROTOCOL.

    Description of Event or Problem · 1

    FILL VOLUME: NAFLON RATE: NA. PROCEDURE: UNKNOWN CATHPLACE: NA. A DISTRIBUTOR REPORTED THAT THERE WAS A PCA BUTTON NOT WORKING. DATE OF EVENT AND FURTHER INFORMATION WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333701 EASYPUMP C-BLOC: 400ML, 5ML/HR + 5ML / 60 MIN ELASTOMERIC PUMP MEB I-FLOW, LLC 4440006 0200911970

    Patients

    Seq Age Sex Outcome Treatment
    1