BEUDAMED
    FDA Adverse Event Other Summary report: N

    LT270-132, EASYPUMP, 270ML, 2ML/HR

    MDR report key: 2933191 · Received January 15, 2013

    Report

    Report Number
    2026095-2012-00261
    Event Type
    Other
    Date Received
    January 15, 2013
    Date of Event
    April 20, 2012
    Report Date
    October 10, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE INVOLVED IN INCIDENT WAS RECEIVED FOR EVAL AND INVESTIGATION. A VISUAL EXAM AND FILL PRESSURE TEST WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR THE LOT NUMBER REPORTED. THE DEVICE LOT MET MANUFACTURING SPECS PRIOR TO RELEASE. RESULTS: THE PUMP WAS FILLED WITH SALINE AND REQUIRED LESS THAN THE MAXIMUM ALLOWABLE FILL PRESSURE. THE FULL PUMP HAD AN ASYMMETRIC SHAPE. CONCLUSIONS: THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THERE WAS NO FAILURE DETECTED AND THE PRODUCT WAS WITHIN SPEC. I-FLOW'S TECHNICAL BULLETIN STATES: AT TIMES, THERE IS HIGH PRESSURE INSIDE THE ELASTOMERIC BLADDER THAT CREATES RESISTANCE WHEN FILLING THE PUMP. HOWEVER, WITH ENOUGH FORCE APPLIED, THE PRESSURE WILL BE OVERCOME AND THE PUMP CAN CONTINUE TO BE FILLED. PLEASE NOTE THAT ASYMMETRICAL FILLING OF THE PUMP MAY ALSO CAUSE RESISTANCE DURING FILLING ONCE ONE SIDE HAS COMPLETELY FILLED AND THE OTHER BEGINS TO EXPAND. ASYMMETRICAL FILLING, HOWEVER, DOES NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. FILLING DIFFICULTY DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. I-FLOW IS FILING THIS REPORT IN RESPONSE TO AN EU VIGILANCE REPORT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS, AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: SALINE SOLUTION. FILL VOLUME: NA. FLOW RATE: NA. PROCEDURE: NA. CATHPLACE: NA. IMPOSSIBLE TO FILL THE PUMP WITH SALINE SOLUTION. NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23084 LT270-132, EASYPUMP, 270ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04434376 192511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA