BEUDAMED
    FDA Adverse Event Other Summary report: N

    7" SMALLBORE PRESSURE INFUSION EXT. SET

    MDR report key: 3151877 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00029
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    September 14, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION AND FOLLOW UP WITH THE FACILITY RISK MANAGEMENT: THE FACILITY CONDUCTED INTERNAL INVESTIGATIONS AND REPORTED THE LOOSE CONNECTIONS/LEAKAGE PROBLEM WERE ONLY OCCURRING FOLLOWING PATIENT'S/SET-UPS FOLLOWING TRANSPORT TO RADIOLOGY. THE SAME DEVICE SETS/SET-UPS WERE USED THROUGHOUT THE HOSPITAL/VARIOUS UNITS WITH NO ISSUES. THE INTERNAL INVESTIGATIONS IDENTIFIED INCONSISTENT TECHNIQUES/ USER RELATED ISSUES WERE CAUSING AND/OR CONTRIBUTING TO THE PRODUCT ISSUES. THE INVOLVED FACILITY MANAGEMENT AND RISK MANAGEMENT STAFF CONCLUDED THAT THE ICU MANUFACTURING SETS DESIGN AND COMPONENTRY WERE NOT DEFECTIVE AND AS SUCH WERE NOT THE CAUSE OF THE REPORTED INCIDENTS. IN ADDITION TO RE-EDUCATION AND RE-TRAINING OF INVOLVED STAFF, ICU MEDICAL SERVICE REPS WERE ABLE TO OFFER AND PROVIDE AN ALTERNATIVE DEVICE SET CONFIGURATION THAT FEATURED A "FIXED LOCK" COMPONENT IN PLACE OF THE EXISTING SETS ROTATING LUER COMPONENT. THE FACILITY HAS NOT EXPERIENCED ANY ADD'L OR REPEAT INCIDENTS SINCE CONVERTING TO THE EXTENSION SETS WITH THE "FIXED LOCK" COMPONENTRY. A (B)(4) REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/SIMILAR ISSUE RECORDED NO ADD'L REPORTS AND/OR INVESTIGATIONS CONFIRMING A MFG/DESIGN RELATED NON-CONFORMANCE. CONCLUSION: THE INVOLVED B33213 DEVICE SET WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE OF THE PROBLEM IS UNK. THIS COMPLAINT AND ASSOCIATED INFO HAVE BEEN ENTERED IN THE MANUFACTURER'S DATABASE FOR ANALYSIS AND TRENDING.

    Description of Event or Problem · 1

    (B)(4) REPORT RECEIVED CONCERNING ATTACHMENT AND LEAKAGE INCIDENT WITH USE OF B33213, 7" SMBORE PRESSURE INFUSION EXT SET W/REMV MICROCLAVE, LOT NUMBER UNKNOWN. THE FACILITIES REPORT STATES "IV WAS LOOSE AND CAME APART DURING INJECTION..." THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223021 7" SMALLBORE PRESSURE INFUSION EXT. SET PRESSURE INFUSION EXT. SET FPA ICU MEDICAL, INC. B33213 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR SYRINGE| POWER INJECTOR EQUIPMENT