BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" PRESSURE INFUSION EXT.W/REMV. MICROCLAVE

    MDR report key: 3973114 · Received June 5, 2014

    Report

    Report Number
    2025816-2014-00063
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: ALTHOUGH REQUESTED, THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. MANUFACTURER'S INVESTIGATION; EVAL CODES: METHOD - A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR (B)(4)/SIMILAR ISSUES DID RECORD ADD'L REPORTS/INVESTIGATIONS. A REVIEW OF THOSE DEVICE RETURN INVESTIGATIONS IDENTIFIED MIXED FINDINGS INCLUDING USAGE/ERRORS; NO DEFECT FOUND; UNK. THERE WERE NO FINDINGS THAT IDENTIFIED/VERIFIED A CONTRIBUTING MFG/DESIGN RELATED NON-CONFORMANCE. FINDINGS: THE INVOLVED DEVICES/SET-UPS WERE NOT RETURNED FOR ANALYSIS AND VERIFICATION. THE EXACT CAUSE(S) OF THE REPORTED PRODUCT EXPERIENCES/ISSUES ARE UNK. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN ENTERED IN THE MANUFACTURERS DATABASE FOR ANALYSIS AND TRENDING.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING ATTACHMENT/LEAKAGE CONCERNS WITH USE OF ONE 12514-01 7" PRESSURE INFUSION EXIT SET Q/MICROCLAVE CLEAR. IT WAS REPORTED THAT THE "OPTION LOCK ON EXTENSION SET 12514-01 WAS DISCONNECTING FROM THE CATHETER. THE THREADING DOES NOT MATCH UP WITH THREADING ON THE OPTION LOCK (RESULTING IN) LEAKAGE."THE FACILITIES DIRECTOR OF EMERGENCY SVS REPORTED THIS PRODUCT ISSUE RESULTED IN "..DELAY IN CARE DUE TO THE IV CATHETER COMING APART DURING CONTRAST INJECTIONS. WHEN THE CATHETER CAME APART..ONLY A PORTION OF CONTRAST WAS INJECTED THE STUDY HAD TO BE RESCHEDULED. THE STUDY IS BASED ON HOW FAST THE CONTRAST IS TAKEN UP AND IF THERE IS ALREADY A SMALL PORTION OF CONTRAST PRESENT THEY HAD TO WAIT UNTIL IS REABSORBED AND DO THE TEST ALL OVER AGAIN, THUS CAUSING A DELAY IN DIAGNOSIS AND THEREFORE A CRITICAL DELAY IN CARE.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328417 7" PRESSURE INFUSION EXT.W/REMV. MICROCLAVE PRESSURE INFUSION EXT FPA ICU MEDICAL, INC. 12514-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI