BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV NEONATAL MONITORING KIT

    MDR report key: 3952859 · Received June 5, 2014

    Report

    Report Number
    2025816-2014-00055
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    February 16, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: ONE (1) PARTIAL 42286-05 TRANSPAC IV NEONATAL MONITORING KIT WAS RETURNED. VISUAL ANALYSIS RECORDED THE 42586-05 FLUSH CLIP WAS DETACHED FROM THE SQUEEZE FLUSH. THERE WERE NO OTHER VISUAL ABNORMALITIES, COMPONENT DEFECTS. ENGINEERING TESTING AND ANALYSIS: THE SQUEEZE FLUSH CLIP WAS REATTACHED AND "SNAPPED" BACK ONTO THE SQUEEZE FLUSH. THE SET WAS THAN ATTACHED TO THE LAB WATER SOURCE WHERE THE SQUEEZE FLUSH COMPONENTS WERE ACTIVATED. THE RESULTS RECORDED NO ATTACHMENT, FLOW AND OR FLUSH ISSUES WERE REPLICATED. WATER FAST FLUSHED THROUGH THE DEVICE WITH NO ISSUES. THE ENGINEER REPORT NOTED THAT IF THE SQUEEZE FLUSH CLIPS ARE FOUND SEPARATED IN THE PACKAGE, THEY CAN BE REATTACHED BY SNAPPING THEM BACK INTO THE SQUEEZE FLUSH ON THE SET AND USED NORMALLY. ENGINEERING TESTING AND ANALYSIS OF THE CURRENT CLIP COMPONENTS INCLUDING MATERIAL ATTRIBUTES AND CLIP DESIGN WAS PERFORMED. THE RESULTS OF THEIR EFFORTS IDENTIFIED A MATERIAL CHANGE(S) TO THE FLUSH CLIP COMPONENTS THAT INCREASED REMOVAL FORCE WHILE STILL ALLOWING FOR THE FLEXIBILITY NEEDED TO HOLD ONTO THE ASSEMBLY. VALIDATION AND QUALIFICATION OF THIS COMPONENT CHANGE HAVE BEEN COMPLETED. CURRENT BUILD REFLECTS THIS COMPONENT IMPROVEMENT. MFG LOT BUILD RECORD REVIEW: A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT# 2772915 (MFR DATE 11/2013) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. FINDINGS: THE REPORTED COMPONENT ATTACHMENT ISSUE WAS CONFIRMED. THE SQUEEZE FLUSH CLIP MATERIAL HAS BEEN CHANGED TO A MORE ROBUST MATERIAL WHICH SHOULD ADDRESS THE PROBLEM THAT WAS ENCOUNTERED. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN ENTERED IN THE MFR'S DATABASE FOR ANALYSIS AND TRENDING.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED CONCERNING COMPONENT CONNECTION ISSUES WITH ONE 42586-05 TRANSPAC IV NEONATAL MONITORING KIT. THE REPORT STATES ATTENDING CLINICIAN"...WAS STRINGING FLUIDS FOR A NEW ARTERIAL LINE. WHEN SHE OPENED THE PACKAGE FOR THE TRANSDUCER, THE YELLOW PIECE WAS NOT ATTACHED TO THE REST OF THE UNIT. IT WOULD NOT GO BACK TOGETHER, SO SHE OBTAINED A DIFFERENT TRANSDUCER FOR THE LINE". THERE WAS NO DIRECT PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329467 TRANSPAC IV NEONATAL MONITORING KIT TRANSPAC IV NEONATAL MONITORING KIT DRS ICU MEDICAL, INC. 42586-05 2772915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA