BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE SECTION H10

    MDR report key: 16960811 · Received May 19, 2023

    Report

    Report Number
    9615050-2023-00142
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 14, 2008
    Report Date
    April 24, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    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 LIST # 11962-78, CONFIGURATION IS NOT AN ICU MEDICAL MANUFACTURED DEVICE. 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.

    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. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED DUE TO THE UNKNOWN LOT NUMBER. D1 - FULL PRODUCT DESCRIPTION - LIFESHIELD¿ LATEX-FREE PRIMARY I.V. SET, CONVERTIBLE PIN, 100 INCH WITH BACKCHECK VALVE AND 2 CLAVE¿ PORTS PIGGYBACK MICRODRIP¿ WITH OPTION-LOK¿.

    Additional Manufacturer Narrative · 0

    ON (B)(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

    THE EVENT WAS REPORTED VIA MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4)) AND STATED AS FOLLOWS: ¿ HOSPIRA CHANGED ROLLER CLAMPS LAST YEAR IN AN ATTEMPT TO IMPROVE PRODUCT, BUT THE NEW ROLLER CLAMPS SIMPLY DON'T DO AS WELL. SO WE HAVE GONE BACK TO THE OLDER ONES. I AM THINKING YOU HAVE RUN INTO A BATCH OF THESE OLDER CLAMPS, WHICH FOR THE MOST PART WORK FINE - BUT THERE ARE SOME LOTS THAT HAVE SHOWN INCONSISTENCY IN TOTALLY SHUTTING OFF THE FLOW, OR NOT BEING ABLE TO REGULATE AS WELL. THIS SHOULD BE A LIMITED EXPERIENCE AND NOT A PERMANENT PROBLEM.¿ THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074868 SEE SECTION H10 SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. UNKNOWN 00(01)(17)(10)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown