BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP LT 270-132: 270 ML, 2 ML/HR

    MDR report key: 4574722 · Received March 2, 2015

    Report

    Report Number
    2026095-2015-00088
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Date of Event
    January 21, 2015
    Report Date
    February 10, 2015
    Manufacturer
    HALYARD
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL INSPECTION WAS PERFORMED AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THERE ARE NO DEVICE TESTING RESULTS AVAILABLE AS THE INVESTIGATION AND EVAL ARE CURRENTLY IN PROGRESS; HOWEVER, THE DHR WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMITY REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. ONCE THE ANALYSIS AND INVESTIGATION ARE COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: 325 ML. FLOW RATE: 2 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: CHEST (LEFT UPPER THORAX). INFUSION STARTED ON (B)(6) 2015. INFUSION ENDED ON (B)(6) 2015. AN INTERNATIONAL DISTRIBUTOR REPORTED THAT AN INFUSION ENDED SOONER THAN EXPECTED. IT WAS REPORTED AS "THE DRUG FINISHED EARLY. THE PUMP WAS PREPARED FOR 7 DAYS, BUT FINISHED IN 4.5 DAYS." FOLLOWING THE EVENT, THE PT EXPERIENCED MILD ORAL APTHAE THAT REQUIRED UNSPECIFIED ORAL CARE. THE PT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143062 EASYPUMP LT 270-132: 270 ML, 2 ML/HR MEB HALYARD 04434376 0200995909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DRUG: 46.5 ML 5-FU| 278 ML SALINE