BEUDAMED
    FDA Adverse Event Other Summary report: N

    LF HIGH FLOW CVC CATHETER

    MDR report key: 1732079 · Received June 10, 2010

    Report

    Report Number
    2025816-2010-00027
    Event Type
    Other
    Date Received
    June 10, 2010
    Date of Event
    December 2, 2009
    Report Date
    March 13, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE INVOLVED DEVICE WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE OF THE REPORTED PROBLEM CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    COMPLAINT REC'D VIA RECEIPT OF UFMW REPORTING COMPONENT BREAKAGE PROBLEMS AND LABELING CONCERNS INVOLVING ONE (1) 41401-23 LF HIGH FLOW CVC 3 LUMAN CATHETER. THE REPORT STATES THAT ON (B)(6) 2009 "RN CONNECTED CONTRAST INJECTOR TO CENTRAL LINE. AT SOME POINT A POP WAS HEARD. THE CENTRAL LINE HAD CRACKED IN THE MIDDLE OF ONE OF THE EXTERNAL PORTS (UNK WHICH PORT,....THOUGHT TO BE THE PROXIMAL PORT...). THE CRACK WAS APPROX. EQUAL DISTANCE FROM THE HUB TO THE PORT END. THE SCAN WAS COMPLETED,... CONTRAST MEDIA WAS INJECTED. THIS REQUIRED A NEW LINE TO BE INSERTED. NO HARM TO THE PT." THE UFMW ALSO REPORTS THAT THE FACILITY HAD "CONCERNS THAT THERE WAS NO INFO REGARDING PSI LEVELS ON THE CATHETER LABEL ITSELF ALTHOUGH IT APPEARS OBVIOUS THAT THE CATHETER IS DESIGNED FOR BLOOD PRESSURES AND FOR INFUSING ROUTINE SOLUTIONS.... CALLED A HIGH FLOW CATHETER; IT WAS FELT THE LABEL INFO WAS NOT OBVIOUS...". THE 41401-23 DEVICE WAS NOT RETURNED TO THE MFR. FOR ANALYSIS AND CONFIRMATION. A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT# 76-545-LA (MFG DATE 04/2009) SHOWS (B)(4). A TWO (2) YR REVIEW OF THE COMPLAINT DATABASES FOR THIS LIST#/SIMILAR PROBLEMS RECORDED NO ADD'L REPORTS OR INVESTIGATIONS IDENTIFYING A MFG/DESIGN PROBLEM. A REVIEW OF THE DEVICE LABELING WAS ALSO PERFORMED. THE LABELED INSTRUCTIONS ARE IN COMPLIANCE WITH STANDARDS OF PRACTICE. HOSP PROTOCOLS AND POLICIES ARE GENERALLY REQUIRED TO VALIDATE THEIR INSTITUTIONAL STANDARDS AS RECOMMENDED BY AACN PROCEDURE MANUAL FOR CRITICAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LF HIGH FLOW CVC CATHETER PULMONARY CATHETER FOZ ICU MEDICAL, INC. 41401-23 76-545-LA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR CONTRAST INJECTOR, MFR MAKE MODEL UNK