BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC MONITORING KIT

    MDR report key: 3252636 · Received July 18, 2013

    Report

    Report Number
    2025816-2013-00062
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFRS INVESTIGATION: DEVICE RETURN: TWO USED/PARTIAL 011-46107-16 SINGLE LINE MTG. KITS WERE RETURNED. VISUAL INSPECTION AND ANALYSIS OF THE ¿AS-REC¿D¿ COMPONENTS/PARTIAL KITS IDENTIFIED THE SPIN COLLARS WERE DAMAGED AND SEPARATED FROM THE TUBING CONNECTIONS. ENGINEER ANALYSIS: THE RESULTS RECORDED THE MALE LUERS WERE BROKEN AT THE TABS OF THE SPIN COLLAR WHICH CAUSED THE SPIN COLLAR TO PULL FREE FROM THE LUER, AND CAUSED THE LUER TO BE PULLED OUT FROM THE CONNECTION. ALTHOUGH NOT ALWAYS REPEATABLE, PREVIOUS INVESTIGATIONS OF THESE TYPES OF COMPONENT DAMAGES/BREAKAGES HAVE DOCUMENTED THAT IF THE COMPONENTS WERE EXPOSED TO EXCESS/PROLONGED ALCOHOL SOLUTIONS AND MATING TECHNIQUES EMPLOYING EXCESS OR UNINTENDED FORCE IT WAS POSSIBLE TO PUSH THE TABS OF THE ROTATOR ONTO THE LOCKING FINS ON THE LUER SLIP SPREADING THE TABS AND CAUSING THEM TO BREAK OFF FROM THE REST OF THE ROTATOR. ALTHOUGH THE EXACT CAUSE(S) ARE UNK, THE MFR IS CONTINUING TO EVALUATE DESIGN AND MATERIAL OPTIONS WITH THEIR COMPONENT VENDOR TO ADDRESS THESE TYPES OF ISSUES. CONCLUSION: VISUAL ANALYSIS OF THE ¿AS-REC¿D¿ PARTIAL KIT COMPONENTS VERIFIED THE REPORTED PRODUCT ISSUE. THE CAUSE(S) OF THE PROBLEM(S) WERE DETERMINED TO BE A RESULT OF INCORRECT USAGE. THIS REPORT HAS BEEN COMMUNICATED TO THE FACILITY AND DISTRIBUTOR REPS. ADD'L MODEL #: 46107.

    Description of Event or Problem · 1

    INTERNATIONAL COMPLAINT (B)(6) REC¿D REPORTING MULTIPLE INCIDENTS WHERE COMPONENT (SPIN COLLAR) BREAKAGES OCCURRED WITH USE OF 011-46106-22; 011-46107-16; 011-46107-17 TRANSPAC IV MTG KITS. THE REPORT STATES "SPIN COLLAR TOTALLY DISINTEGRATE OR BROKE OFF¿" THE FACILITY CLINICIAN DESCRIBED ONE INCIDENT WHERE THE "¿RADIAL ARTERIAL SET¿APPARENTLY BROKE AND THEY NEEDED TO INSERT A NEW FEMORAL LINE TO REPLACE IT. IT LOOKS LIKE THE LUER END THAT SCREWS ONTO THE CANNULA HAS BROKEN OFF." ALTHOUGH F/U INQUIRIES CONFIRMED THERE WERE NO SERIOUS INJURIES, ADVERSE PT CONSEQUENCES THERE WAS ONE INCIDENT WHERE AN UNSCHEDULED UNDEFINED MEDICAL PROCEDURE WAS REQUIRED. THE MONITORING KIT DEVICES WERE PRE-TESTED AND IN USE LESS THAN 2 DAYS. THE DEVICES WERE CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335269 TRANSPAC MONITORING KIT MONITORING KIT GWM ICU MEDICAL INC. 011-46106 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI