BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE L

    MDR report key: 17121385 · Received June 13, 2023

    Report

    Report Number
    9615050-2023-00169
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 4, 2023
    Report Date
    May 23, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN D4 AND H4 SECTIONS.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER, IS YET TO BE RECEIVED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF AIR IN LINE COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF AIR IN LINE COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. LOT HISTORY REVIEW WAS PERFORMED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A BLOOD ADMINISTRATION PLUMSET¿, 200 MICRON FILTER, 110 INCH IN WHICH THE CUSTOMER STATED THAT THE DEVICE IS LETTING AIR BACK IN. THE EVENT OCCURRED DURING PATIENT INFUSION AND 2 UNITS OF BLOOD WERE ORDERED ON A PATIENT AS AN INTERVENTION. WHILE TRYING TO INFUSE THE BLOOD UTILIZING THE ICU MEDICAL PLUM 360 AND THE ICU MEDICAL PRIMARY PLUM Y-TYPE BLOOD SET THE TUBING FILLED WITH AIR BUBBLES, AND PUMP GAVE HIGH PRESSURE WARNING AND THEN THE BLOOD ENDED UP INFILTRATING THROUGH THE TUBING AND THE MICRON FILTER. THEY CHANGED OUT THE BLOOD TUBING SET AND EXPERIENCED THE SAME PROBLEM. THEY TRIED TO UTILIZE GRAVITY BLOOD TUBING, BUT NONE WAS TO BE FOUND IN THE HOSPITAL. A CALL WAS PLACED TO ICU MEDICAL, INC AND A NURSE CAME DOWN AND DECREASED THE PSI ON THE PUMP FROM 10 PSI TO 5 PSI WHICH ALLOWED THE PUMP TO INFUSE THE BLOOD WITHOUT FURTHER ISSUE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214102 PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE L SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 1421228 12368806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ICU MEDICAL PLUM 360 INFUSION PUMP| PRIMARY PLUM Y-TYPE BLOOD SET -14212-28 ICU MED