BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC IV MONITORING KIT

    MDR report key: 3314197 · Received August 16, 2013

    Report

    Report Number
    2025816-2013-00091
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG INVESTIGATION ANALYSIS AND EVAL: METHOD: A REVIEW OF THE MFR LOT BUILD DATABASE RECORDS FOR THE REPORTED LOT #2613339 (MFG DATE 12/2012) SHOWS (B)(4) UNITS WERE MFG TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG BUILD CYCLE. A TWO YEAR REVIEW OF THE MANUFACTURER'S DATABASE FOR THIS LIST #42584-05/SIMILAR PRODUCT ISSUE RECORDED NO ADDITIONAL REPORTS/INVESTIGATIONS IDENTIFYING A DESIGN OR MANUFACTURING NON-CONFORMANCE. THE 42584-05 DIRECTIONS FOR USE (DFU) PROVIDES DETAILED INSTRUCTIONS REGARDING PRE-TESTING, PRIMING, PURGING AIR FROM THE LINES (GRAVITY PRIME ONLY) AND SET-UP DIRECTIONS. THE DFU DOES CAUTION THAT IF THE LINE IS PRIMED IN A FORWARD MANNER UNDER PRESSURE, CARE MUST BE TAKEN TO ASSURE MAX PRESSURE SPECIFICATIONS ARE NOT EXCEEDED. CONCLUSION: THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND INVESTIGATION. THE EXACT CAUSE(S) OF THE REPORTED INCIDENTS/COMPONENT SEPARATION REMAINS UNK.

    Description of Event or Problem · 1

    FDA/MEDSUN REPORT RECEIVED CONCERNING COMPONENT SEPARATIONS/LEAKAGE ISSUES WITH USE OF 42584-05 TRANSPAC IV MONITORING KITS. IT WAS REPORTED THAT "...ON AT LEAST THREE OCCASIONS THE TRANSPAC IV TUBING 'SNAPPED' AT THE CONNECTION JUST PROXIMAL TO THE FLUSH ADAPTOR LEAVING THE MALE CONNECTOR PORTION WITHIN THE FEMALE. THE TUBING WAS UNDER PRESSURE; HOWEVER, THE STAFF REPORT THE PRESSURE BAG WAS NOT OVER-INFLATED AT THE TIME OF EITHER INCIDENT. WHEN THE TUBING SEPARATED IT CREATED THE POTENTIAL FOR AN 'OPEN' SYSTEM (UNLESS EITHER OF THE TWO DISTAL STOPCOCKS WERE TURNED OFF TO THE PT). IT ALSO ALLOWED FLUID UNDER PRESSURE TO SATURATE THE SURROUNDING AREA UNLESS THE ROLLER CLAMP WAS QUICKLY CLOSED." THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. IT IS THE MANUFACTURER'S UNDERSTANDING THAT THE 42584-05 MONITORING KITS WERE SUCCESSFULLY PRE-TESTED, PRIMED WITH NO ISSUES NOTED AT THAT TIME. ALTHOUGH ADDITIONAL USAGE, EVENT INFORMATION WAS REQUESTED, AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE. DEVICE STATUS: THE INVOLVED 42584-05 DEVICES OR SAME LOT SAMPLE WERE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS AND CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396624 TRANSPAC IV MONITORING KIT MONITORING/MTO/ACC DRS ICU MEDICAL, INC. 42584-05 2613339

    Patients

    Seq Age Sex Outcome Treatment
    1 NI