BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTICATH

    MDR report key: 1810653 · Received July 27, 2010

    Report

    Report Number
    2025816-2010-00076
    Event Type
    Other
    Date Received
    July 27, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 7, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORD REVIEW: A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 87-493-K4 (MFG. 03/2010) SHOWS (B)(4) UNITS WERE MFG, TESTED, INSPECTED AND RELEASED. CONCLUSION: THE REPORTED PROBLEM WAS NOT REPLICATED OR CONFIRMED. THERE WERE NO LEAKS, OCCLUSIONS AND OR NON-CONFORMANCES OF THE DEVICES COMPONENTRY THAT WOULD HAVE CAUSED/CONTRIBUTED TO THE REPORTED READING PROBLEM. CAUSE(S) OF THE REPORTED PRODUCT EXPERIENCE IS UNKNOWN.

    Description of Event or Problem · 1

    (B)(4) REPORT RECEIVED REPORTING READING PROBLEMS WITH TWO (2) 50337-06 PA CATHETERS. THE REPORT STATES "BEFORE INSERTING THE PA CATHETER (PHYSICIAN) OCCLUDED THE TIP OF THE CATHETER... TO CONFIRM THAT THE CATHETER IS ABLE TO DETECT CHANGE IN PRESSURE¿ THE CATHETER DID NOT RESPOND TO THE PRESSURE OCCLUSION TEAR. THE CATHETER WAS RE-ZEROED MULTIPLE TIMES, ALL THE PORTS WERE FLUSHED AND THE ENTIRE SET-UP FROM THE PRESSURE BAG, TRANSDUCERS TO THE MONITORS AND CABLES WERE CHECKED SEVERAL TIMES FOR LEAKS AND DISCONNECTIONS. WHEN THE PROBLEM DID NOT RESOLVE AFTER THESE MEASURES, A NEW PA CATHETER WAS TESTED WITH SAME RESULT." THE REPORT ALSO STATES A THIRD PA CATHETER WAS TESTED, BUT THIS TIME IT SUCCESSFULLY PASSED THE OCCLUSION TEST AND, ONCE IT WAS INSERTED, EASILY DETECTED THE PA PRESSURES." THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE TWO (2) 50337-06 PA CATHETERS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS AND INVESTIGATION. MANUFACTURER'S INVESTIGATION: VISUAL ANALYSIS RECORDED NO OBVIOUS ABNORMALITIES. DIMENSIONAL AND FUNCTIONAL TESTS WERE PERFORMED ON EACH OF THE TWO RETURNED CATHETERS. DIAMETER TESTS PERFORMED RECORDED NO OUT OF SPEC CONDITIONS. THE TWO RETURNED DEVICES WERE LEAK TESTED/OCCLUSION TESTED PER PRODUCT SPECIFICATIONS. THE RESULTS RECORDED NO OUT OF SPEC. CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICATH PA CATHETER DYG ICU MEDICAL, INC. 50337-06 87-493-K4

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR CABLES| MONITOR (NOI) MFR. MODELS UNKNOWN