BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" PRESSURE INFUSION (10 ML/SEC) EXT SET

    MDR report key: 2911216 · Received December 14, 2012

    Report

    Report Number
    2025816-2012-00059
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 11, 2012
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S DEVICE ANALYSIS: TWO (2) USED Z3446 7" PRESSURE INFUSION EXT SETS WERE RETURNED. VISUAL INSPECTION OF THE AS-RECEIVED Z3446 SETS TUBING COMPONENTS CONFIRMED THEY WERE SPLIT/DAMAGED. ONE OF THE RETURNED SETS CONNECTOR WAS RECESSED. DURING DECONTAMINATION, THE Z3446 SET'S CONNECTOR DID RETURN TO CORRECT CLOSED POSITION AND WAS NO LONGER RECESSED. FUNCTIONAL AND PERFORMANCE (LIMITED) TESTING AND ANALYSIS WAS PERFORMED ON THOSE SET COMPONENTS THAT WERE NOT DAMAGED. THE RESULTS RECORDED NO MANUFACTURING NON-CONFORMANCES OR PERFORMANCE ISSUES. ATTACHMENT/CONNECTION ISSUES - THE MFR HAS RECOMMENDED/PROVIDED ADD'L INSERVICING TO THE FACILITY ON THE Z3446 SETS SPIN LOCK FEATURES. PULLING BACK THE SPIN COLLAR AND INSERTING THE LUER SLIP WITH A FIRM PUSH AND 1/4 TURN WILL RESULT IN THE BEST POSSIBLE CONNECTION. THIS ENSURES THAT YOU ARE NOT RELYING ON TURNING THE SPIN COLLAR ALONE TO FACILITATE THE ADEQUATE LUER DEPTH INTO THE MATING DEVICE. AFTER THESE COMPONENTS ARE CONNECTED, THE SPIN COLLAR CAN THEN BE LOCKED DOWN. THE MFR CONTINUOUS IMPROVEMENT INITIATIVES HAVE ALSO IDENTIFIED MINOR COMPONENT CHANGES THAT HAVE EXTENDED THE LUER THREADS RESULTING IN THE START OF THE THREAD BEING FORWARD IN AN AXIAL POSITION TO FURTHER ADDRESS INCORRECT USAGE/ATTACHMENT TECHNIQUES. SPLIT/DAMAGED TUBING - THE MFR HAS RECOMMENDED AND PROVIDED ADD'L INSERVICING TO THE FACILITY. TUBING/BURS SPLITS CAN BE PREVENTED BY REDUCING THE INJECTION RATE AND/OR CATHETER SIZE SELECTION, WHICH MINIMIZES THE PRESSURE IN THE TUBING. THE MFR'S CONTINUOUS IMPROVEMENT INITIATIVES HAVE ALSO IDENTIFIED THAT ALTHOUGH NOT ALWAYS REPEATABLE USE OF 22G CATHETERS FOR INFUSION INSTEAD OF THE USUAL 18G CATHETERS, CAN CREATE A LARGER BACKPRESSURE ON THE SETS THAN WHAT WOULD BE SEEN UNDER NORMAL PRESSURE INFUSION APPLICATIONS. ENGINEERING TESTING AND EVALUATIONS IDENTIFIED A CHANGE TO THE TUBING COMPONENT MATERIAL TO A HIGHER DUROMETER. THIS PRODUCT IMPROVEMENT HAS BEEN SHOWN TO INCREASE THE MAXIMUM BURST CAPABILITY OF TUBING WHEN DIMENSIONS ARE HELD CONSTANT. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN ENTERED IN THE MFR'S DATABASE FOR ANALYSIS, MONITORING, AND TRENDING.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING DISCONNECTS/LEAKAGES WITH USE OF Z3466 7" PRESSURE INFUSION (10 ML/SEC) EXT SET W/REMV MICROCLAVE. FACILITY REPORTS "¿SEVERAL COMPLAINTS¿SEVERAL PTS IV BECOME DISCONNECTED AND BLEED¿MEDICAL ONCOLOGY HAD TO TRANSFUSE ON PT WHO HAD AN INADVERTENT DISCONNECTION¿RADIOLOGY HAD ONE TUBING EXPLODE WHEN USING A PRESSURE INJECTION". ALTHOUGH REQUESTED, NO ADD'L INFO, FOLLOW-UP RESPONSES RECEIVED SPECIFIC TO THE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7" PRESSURE INFUSION (10 ML/SEC) EXT SET IV EXTENSION SETS FPA ICU MEDICAL INC. Z3446 13-216-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NI RADIOLOGY EQUIP., ADMINISTRATION IV SETS NOI