BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM V/NV CKV 2SMS 20DP 20PK

    MDR report key: 524074 · Received May 5, 2004

    Report

    Report Number
    2016493-2004-00010
    Event Type
    Injury
    Date Received
    May 5, 2004
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "IV TUBING BROKE AT MED PORT. PT WAS FOUND WITH APPROX. 50-100CC'S OF BLOOD MIXED WITH IV FLUID IN BED. THE IV TUBING BROKE AT LOWEST PORT. PT HAS SICKLE CELL DISEASE AND SUFFERED A DROP IN HGB REQUIRING A BLOOD INFUSION." CUSTOMER WAS CALLED BY ALARIS MEDICAL SYSTEM FOR ADDITIONAL INFORMATION. CUSTOMER DID NOT REPORT THIS ISSUE TO ALARIS AT TIME OF OCCURRENCE. CUSTOMER WAS ABLE TO SEND IN THE TUBING PART FOR INVESTIGATION. CUSTOMER DID NOT HAVE ANY ADDITIONAL INFORMATION RELATED TO THE PT. INCIDENT OCCURRED IN 2003. SUMMARY OF EVALUATION: CUSTOMER RETURNED ONE SMARTSITE PISTON AND ONE WHITE CAP COVERED WITH DRIED BLOOD FOR ANALYSIS. VISUAL INSPECTION OF SMARTSITE PISTON UNDER MAGNIFIER MICROSCOPE REVEALED NO EVIDENCE OF A NEEDLE PUNCTURE ON THE TOP OF THE SMARTSITE VALVE (BLUE PISTON AREA). INSPECTION OF WHITE CAP SHOWED NO EVIDENCE OF STRESS MARKS OR CRACKS. NO OTHER PARTS OR PIECES WERE RETURNED. THE PARTS WERE INSPECTED CAREFULLY BUT NO DETERMINATION OF FAILURE COULD BE MADE WITH ONLY THE PARTS RECEIVED. ROOT CAUSE OF THE DAMAGED PORT COULD NOT BE VERIFIED DUE TO ONLY THE PORT BEING RETURNED AND NOT THE ENTIRE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM V/NV CKV 2SMS 20DP 20PK IV TUBING FPA ALARIS MEDICAL SYSTEMS 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention