BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV MONITORING KIT

    MDR report key: 5466750 · Received February 29, 2016

    Report

    Report Number
    2025816-2016-00008
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    December 30, 2015
    Report Date
    February 29, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3072257 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN JULY OF 2015 WITH NO ANOMALIES. PRODUCT RECEIPT AND VISUAL ANALYSIS: (B)(4) 2016 - RECEIVED THREE (3) - TWO NEW AND ONE USED 011-46110-71. TRANSPAC MONITORING KIT, LOT# 3072257, ONE (1) USED BD 60ML SYRINGE. THE BD SYRINGE WAS CONNECTED TO THE RED RING MICROCLAVE. A CHANNEL LEAK WAS IDENTIFIED AND THE BONDING SITE OF THE FEMALE LUER AND THE STOPCOCK THAT IS CONNECTED TO THE SAFESET SYRINGE. A SECOND LEAK WAS IDENTIFIED AT THE INJECTION PORT. FUNCTIONAL/PERFORMANCE TESTING: THE USED AND UNUSED UNITS WERE LEAK TESTED PER SOP.X.2500-0037. NO LEAKING WAS OBSERVED IN THE UNUSED UNITS. LEAKING WAS OBSERVED FROM CHANNEL LEAK FROM A HARD TO HARD SOLVENT BOND BETWEEN THE SAFESET RESERVOIR AND THE 1 WAY STOP COCK THAT IS BONDED TO. IT WAS OBSERVED THAT THE BUNG HOUSING WAS CRACKED WHICH ALSO LEAKED. ANALYSIS SUMMARY: CONFIRMATION OF THE UNIT THAT THE CUSTOMER SAW AIR IN THE LINE COULD NOT BE CONFIRMED AS IT WAS DISCARDED. THE REPORTED COMPLAINT OF LEAKING/AIR BUBBLES GETTING IN THE SYSTEM IS CONFIRMED ON THE OPENED UNIT THAT WAS PRIMED BUT UNUSED ON A PATIENT. THE ROOT CAUSE OF THE FAILURE WAS FROM A CHANNEL LEAK IN A HARD TO HARD SOLVENT BOND. THE TWO NEW UNITS WERE PRESSURE TESTED AND MET ALL PERFORMANCE SPECIFICATIONS. CORRECTIVE ACTION: IN (B)(4) 2015 AN AIR LEAK TEST WAS IMPLEMENTED FOR THIS ISSUE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 011-46110-71. TRANSPAC MONITORING KIT, LOT# 3072257 (MFGD 07/2015). REPORT STATES, "(B)(6) HAD MENTIONED THEY WERE GETTING AIR IN THE LINE WHEN TAKING BLOOD SAMPLES AND SAID THAT THE CORRECT DFU HAD BEEN FOLLOWED WITH SETTING UP AND PRIMING AND OBTAINING A BLOOD SAMPLE AND THERE SHOULD BE NO REASON FOR AIR BUBBLES GETTING INTO THE SYSTEM. UNFORTUNATELY THAT PARTICULAR KIT WAS THROWN AWAY. WHILE PRIMING ANOTHER KIT AIR KEPT ON GETTING INTO THE SYSTEM AND IT NOTED THAT AT THE JOIN AT THE TIP OF THE RESERVOIR AND THE ONE WAY TAP IT WAS LEAKING." NO SERIOUS ADVERSE PATIENT CONSEQUENCES REPORTED FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122203 TRANSPAC IV MONITORING KIT TRANSPAC IV MONITORING KIT DRS ICU MEDICAL, INC. 011-46110-71

    Patients

    Seq Age Sex Outcome Treatment
    1