BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED GRAVITY SET

    MDR report key: 16951697 · Received May 18, 2023

    Report

    Report Number
    9617594-2023-00193
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    April 14, 2008
    Report Date
    April 24, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00(01)(17)(10)
    PMA / PMN Number
    K971293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 6, 2017 ICU MEDICAL INC. COMPLETED ACQUISITION OF THE HOSPIRA INFUSION SYSTEMS (HIS) BUSINESS FROM PFIZER INC. IT IS ICU MEDICALS UNDERSTANDING THAT THESE REPORTED 2008 EVENTS, COMPLAINT DATABASE INFORMATION/RECORDS ARE NOT AVAILABLE TO ICU MEDICAL. THE ARCHIVED RECORDS WOULD HAVE BEEN PROCESSED PER THE APPLICABLE PFIZER/HOSPIRA DOCUMENT RETENTION & RECORD DESTRUCTION POLICIES THAT WERE IN PLACE IN 2008.

    Description of Event or Problem · 0

    IT WAS REPORTED ON MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4)) THAT THE NURSE STATED THE INTRAVENOUS (IV) RATE WAS ADJUSTED AS ORDERED, HOWEVER, IT WAS FOUND BY THE SURGEON TO BE INFUSING AT A MUCH HIGHER RATE, THUS PROMOTING AND PROLONGING THE PATIENTS' HYPERTENSIVE STATE. THERE HAVE BEEN NUMEROUS COMPLAINTS FROM STAFF AND ANESTHESIOLOGISTS REGARDING THE DIFFICULTY OF SETTING A DRIP-RATE. IT EITHER RUNS IN VERY QUICKLY OR IS OFF. IT IS VERY DIFFICULT TO REGULATE PRECISELY. ONE PHYSICIAN SAYS IT SEEMS LIKE THE TUBING HAS A "MEMORY" AND THAT HE BEGINS TO HAVE DIFFICULTY REGULATING THE DRIP RATE AS HE MOVES THE ROLLER CLAMP UP OR DOWN THE TUBING, AND HE IS BETTER ABLE TO REGULATE IT. WE HAVE DISCUSSED THE NECESSITY FOR USING IV PUMPS FOR PATIENTS FOR WHICH FLUID REGULATION IS MOST CRITICAL. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907749 UNSPECIFIED GRAVITY SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00(01)(17)(10)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED MEDICATION, UKN MFR