BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBORE EXTENSION SET

    MDR report key: 4781555 · Received May 19, 2015

    Report

    Report Number
    9616066-2015-00601
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Report Date
    April 22, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: BAXTER 50ML IV BAG,10% DEXTROSE INJECTION USP, LOT C967349, EXP 08/16; COVIDIE 3ML FLUSH SYRINGE, 0.9% NACL, LOT 3123436, THERAPY DATE: UNK. CONCLUSION: FIELD LEFT BLANK- NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT OF A LEAK WAS CONFIRMED. VISUAL INSPECTION OF THE EXTENSION SET NOTED NO DAMAGES OR ANY ANOMALIES. FURTHER VISUAL INSPECTION OF THE FILTER VENT UNDER A MICROSCOPE OBSERVED NO OBVIOUS DAMAGES OR ISSUES. FUNCTIONAL TESTING WAS PERFORMED AND THE FLUID WAS NOTED TO FLOW THROUGH THE SUSPECT EXTENSION SET. IT WAS ALSO OBSERVED THAT FLUID WAS LEAKING OUT FROM THE SET'S FILTER VENT. PRESSURE TESTING WAS PERFORMED AND NO LEAKING WAS OBSERVED. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT WAS DUE TO A DAMAGED FILTER VENT MEMBRANE; HOWEVER IT IS NOT KNOWN HOW THE FILTER VENT MEMBRANE GOT DAMAGED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS SEVERAL INSTANCES OF LEAKING FILTERS AT THE AIR VENT ON THEIR EXTENSION SETS OVER THE LAST TWO WEEKS. THE LEAKS HAVE OCCURRED BOTH WHILE PRIMING UNDER THE HOOD IN THE PHARMACY, AND ON THE NICU WHILE GIVING TPN AND LIPIDS. THIS PARTICULAR EVENT WAS NOTED TO BE D10 NS CONTINUOUS IV INFUSION WITH ELECTROLYTES, INFUSING AT 4.8 ML/HR IN THE NICU. THE EXTENSION SETS ARE BEING USED WITH B BRAUN PRIMARY TUBING AND DEVICES. NO PATIENT HARM HAS BEEN REPORTED, HOWEVER IT HAS CAUSED DELAY IN THERAPY AS THE ENTIRE SET-UP MUST BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326745 MINIBORE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MX9166 15015162

    Patients

    Seq Age Sex Outcome Treatment
    1