BEUDAMED
    FDA Adverse Event Other Summary report: N

    SETSOURCE 8" CLAVE PRESSURE INFUSION IV SET

    MDR report key: 3174302 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00014
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION: DEVICE RETURN: ONE (1) USED Z3251, PRESSURE INFUSION (400PSIG) EXT SET WAS RETURNED FOR ANALYSIS AND INVESTIGATION. VISUAL INSPECTION OF THE RETURNED "AS-RECEIVED" Z3251 DEVICE SET CONFIRMED MULTIPLE COMPONENT DAMAGES TO THE SETS Y-CLAVE ND MALE LUER COMPONENTS. ENGINEERING ANALYSIS: THIS SET WAS DESIGNED AND ORDERED WITH BOTH AN INLINE CLAVE CONNECTOR AND A Y-CLAVE CONNECTOR. THE ENGINEERING REPORT NOTES THAT THIS SETS ORDERED DESIGN/COMPONENT FEATURES WILL INFUSE AT 400 PSIG WHEN THE SETS CLAMP IS ACTIVATED AND INFUSED THROUGH THE SETS Y-CLAVE. WHEN PRESSURIZING THE INLINE STRAIGHT CLAVE, THE Y-CLAVE BACK PRESSURES ARE EXCEEDED AND CAN RESULT IN THE COMPONENT DAMAGES SEEN ON THE RETURNED SET. CONCLUSION: THE REPORTED PRODUCT ISSUE WAS VISUALLY CONFIRMED. THE MANUFACTURER AND ACCOUNT MANAGER HAVE PROVIDED THIS INVESTIGATION; RESULTS AND CONDUCTED INSERVICING WITH APPLICABLE STAFF TO REVIEW THE FACILITY'S PROTOCOL AND THE DEVICE SETS COMPONENTS AND INTENDED USAGE. THIS COMPLAINT AND ASSOCIATED INFORMATION HAVE BEEN ENTERED IN THE MANUFACTURER'S DATABASE FOR ANALYSIS AND TRENDING.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED CONCERNING COMPONENT BREAKAGE ISSUE WITH USE OF Z3251 8" PRESSURE INFUSION IV SET. THE REPORT STATES "FLUSHED THE POWER INJECTABLE IV EXTENSION WITH 10CC OF SALINE. HOOKED UP THE POWER INJECTOR TUBING ON THE DISTAL CLAVE ON THE POWER INJECTABLE EXTENSION TUBING. INJECTED 80CC OF ISOVUE 370 AT A RATE OF 5.0 ML/SECOND AND THE PROXIMAL CLAVE BLEW OUT... THE TUBING WAS REMOVED AND THE PROCEDURE WAS CONTINUED BY CONNECTING DIRECTLY TO THE IV CATH... PROBLEM HAS OCCURRED BEFORE." THERE WERE NO REPORTED ADVERSE PATIENT/OPERATOR CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223241 SETSOURCE 8" CLAVE PRESSURE INFUSION IV SET IV SET FPA ICU MEDICAL, INC. Z3251 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR SYRINGE NOI| CT POWER INJECTOR EQUIPMENT