BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POMPE A PERFUSION PLUM 360, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET

    MDR report key: 10372327 · Received August 6, 2020

    Report

    Report Number
    9615050-2020-00178
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 20, 2020
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - THE DEVICE WAS RECEIVED IN GOOD GENERAL CONDITION. THE DEVICE PASSED A FULL PVT WITHOUT ISSUE. THE CUSTOMER SETTINGS WERE RUN ON 10.50AM (B)(6)2020 . LINE A 550 ML FOR (B)(4) HOURS AT A RATE OF 46 ML/HR. THE DEVICE WAS STOPPED THE FOLLOWING MORNING AT 8.00AM. THE DEVICE COMPLETED THE DELIVERY WITHOUT ISSUE ALARMING N161 LINE A COMPLETED. THE VOLUME DELIVERED WAS APPROXIMATELY 559ML. THE COMPLAINT WAS NOT CONFIRMED THROUGH TESTING. NO PROBABLE CAUSE COULD BE DETERMINED. CLINICAL LOG ANALYSIS INDICATES THAT THE PERCEIVED UNDERDELIVERY WAS DUE TO A LARGE NUMBER OF DELAYS FOR DISTAL OCCLUSION ALARMS AND BACKPRIMING. THERE IS ALSO A LOGGED ALARM FOR A BROKEN DISTAL PRESSURE PIN. THE PIN WAS EXAMINED AND FOUND TO BE IN GOOD CONDITION WITH NO VISIBLE DAMAGE NOTED. THE DEVICE PASSED DISTAL OCCLUSION TESTS WITHOUT ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A PLUM 360 PUMP THAT HAD FLOW ISSUES IN THE LAST MONTH. THE DEVICE WAS PROGRAMMED TO INFUSE THE SOLUTION FOR 12 HOURS AND THERE WAS A REPORTED DELAY FOR 3 HOURS, EVEN MORE). THE INFUSION WAS PROGRAMMED ON CHANNEL A: AN UNSPECIFIED SOLUTION OF 550ML FOR 12 HOURS, FROM 20:00H TO 08:00,( FLOW OF 46CC/H). CHANNEL B WAS NOT USED. THE TUBING SET WAS PRIMED AND WAS NOT REPLACED. IT WAS ALSO REPORTED THE CASSETTE DOOR WAS NOT DAMAGED. THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY REPORTED AS THE PUMP HAD TO STAY CONNECTED LONGER AND THE PATIENT DID NOT RECEIVE THE PRODUCT WITHIN THE PRESCRIBED TIME, ALTHOUGH THERE WAS NO NEED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840121 POMPE A PERFUSION PLUM 360, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPEC PLUMSET, MFR ICU MEDICAL, INC.| UNSPEC PLUMSET, MFR ICU MEDICAL, INC.