BEUDAMED
    FDA Adverse Event Other Summary report: N

    7" SMALLBORE PRESSURE INFUSION EXT. SET

    MDR report key: 3151873 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00028
    Event Type
    Other
    Date Received
    May 20, 2013
    Report Date
    November 8, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    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 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 MFG SETS DESIGN AND COMPONENTRY WERE NOT DEFECTIVE AND AS SUCH WERE NOT THE CAUSE OF THE REPORTED INCIDENTS. IN ADDITION TO RE-EDUCATION AND RETRAINING 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 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 REVIEW OF THE MFG LOT DATABASES FOR THE REPORTED LOT NUMBER 2526574 (MFG DATE: 07/01/2012) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. 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 B33038 DEVICE SET(S) WERE 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.

    Description of Event or Problem · 1

    (B)(4) REPORT RECEIVED CONCERNING AN ATTACHMENT AND LEAKAGE INCIDENT WITH USE OF B33038, 7" SMBORE PRESSURE INFUSION EXT SETS. THE FACILITIES REPORT DESCRIBES ONE INCIDENT THAT OCCURRED ON (B)(6) 2012 WHERE "THE IV GAVE WAY AT CONNECTION SITE" A NUMBER OF INCIDENTS DATING BACK TO (B)(6) 2012 WHERE THE PROXIMAL END OF THE HUB THAT GETS SCREWED INTO THE IV CATHETER HAS BEEN LEAKING, RESULTING IN A CHANGE IN PRODUCT TO A MORE SECURE STATIONARY HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222961 7" SMALLBORE PRESSURE INFUSION EXT. SET PRESSURE INFUSION EXT. SET FPA ICU MEDICAL, INC. B33038 2526574

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR SYRINGE NOI| POWER INJECTOR EQUIPMENT