BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULMONARY ARTERY CATHETER

    MDR report key: 1732074 · Received June 10, 2010

    Report

    Report Number
    2025816-2010-00040
    Event Type
    Other
    Date Received
    June 10, 2010
    Date of Event
    December 9, 2009
    Report Date
    March 4, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING COMPONENT BREAKAGE PROBLEM WITH ONE (1) PULMONARY ARTERY CATHETER (LIST/MODEL#/LOT# UNK). THE REPORT STATES ON (B)(6) 2009 "THE BRIDGE ATTACHED TO THE PULMONARY ARTERY (PA) CATHETER BROKE. THIS CAUSED THE END OF THE YELLOW (DISTAL) LUMEN TO BREAK AS WELL, NECESSITATING THE REMOVAL OF THE LINE. FRACTURE OF THE BRIDGE IS UNUSUAL.... NO UNUSUAL FORCE OR TORQUE USED WHEN MANIPULATING THE BRIDGE. NO HARM TO THE PT.....". THE FACILITY (B)(4) REPORT DID INDICATE THE DEVICE WAS AVAILABLE FOR EVAL. THE MFR CONTACTED THE IDENTIFIED (B)(4) REPORTER WHO WAS UNCERTAIN AS TO THE CURRENT STATUS/LOCATION OF THE INVOLVED DEVICE. NO OTHER INFO INCLUDING THE DEVICE LIST; MODEL OR CATALOG # OR LOT# IS KNOWN. AS OF THE DATE OF THIS REPORT THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR ANALYSIS AND CONFIRMATION. THE CATHETER DEVICE WOULD HAVE BEEN PRE-TESTED PRIOR TO PLACEMENT. THERE WERE NO PERFORMANCE ISSUES/DAMAGES NOTED AT THAT TIME. CAUSE OF THE REPORTED EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY ARTERY CATHETER PULMONARY ARTERY CATHETER FOZ ICU MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR