BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA INFUSION SYSTEM

    MDR report key: 6227284 · Received January 5, 2017

    Report

    Report Number
    9681819-2017-00041
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    May 1, 2016
    Report Date
    May 3, 2016
    Manufacturer
    FRESENIUS KABI DEUTSCHLAND GMBH
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, "PIPE ASSEMBLED THE OTHER WAY AROUND WHICH CAUSES BLOOD BACK INTO THE PIPE INSTEAD OF ADMINISTERING THE INFUSION. NO SAMPLE BECAUSE CYTOTOXIC PRODUCT." THE INVESTIGATION SUMMARY REPORT STATES THAT TWO PICTURES WERE RECEIVED FOR INVESTIGATION. WITH THE HELP OF THE PICTURES FROM THE CUSTOMER WE COULD CONFIRM THE COMPLAINT REASON. THE SIK-PUMPENSEGM.VP500 SAFE WAS ASSEMBLED IN A WRONG DIRECTION. UNFORTUNATELY, ONE WORKER ASSEMBLED VP500 WITH WRONG DIRECTION AND 100% VISUAL CONTROL DIDN'T RECOGNIZE THE WRONG DIRECTION PRODUCT. WE PERFORMED VISUAL INSPECTIONS ON ALL RETAIN SAMPLES OF THE COMPLAINED BATCH WITHOUT FINDING ANY NON-CONFORMITY. THE INVESTIGATION OF OUR PRODUCTION DOCUMENTS SHOWED THERE IS A DEVIATION REPORT FOR THIS BATCH. THIS BATCH WAS REWORKED TO CHANGE NEW PUMPENSEGMENT VP500 AND 100% VISUAL CONTROL. THE ROOT CAUSE ACCORDING TO OUR PRODUCTION DEPARTMENT WAS CAUSED DUE TO THE INATTENTION OF THE WORKER DURING THE ASSEMBLY PROCEDURE. TO AVOID THIS ERROR IN FUTURE WE PERFORMED A RE-TRAINING OF THE AFFECTED STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7569 AGILIA INFUSION SYSTEM INFUSION PUMP SYSTEM FRN FRESENIUS KABI DEUTSCHLAND GMBH M46441300S 84446155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention