BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROBORE EXTENSION SET, IV CONNECTOR,.F

    MDR report key: 7837972 · Received August 31, 2018

    Report

    Report Number
    9616066-2018-01473
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    July 1, 2018
    Report Date
    August 5, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403240621
    PMA / PMN Number
    K140831
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. THE CUSTOMER¿S REPORT OF A SMALL LEAK IN THE TUBING JUST ABOVE THE INSERTION POINT IN THE PGE TUBE WAS NOT CONFIRMED. VISUAL INSPECTION OF THE SET SHOWED NO DAMAGE OR ANY ANOMALIES. FUNCTIONAL AND PRESSURE TESTING RESULTED IN FLUID FLOWING FREELY THROUGH THE SET WITH NO ISSUES OR LEAKS OBSERVED. THE ROOT CAUSE OF THE LEAKING WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A NICU PATIENT WAS RECEIVING 0.025 MCG/KG/MINUTE OF ALPROSTADIL (PGE) WHEN THEIR OXYGEN LEVEL BEGAN DE-SATURATING TO THE LOW 70'S. TRACING THE LINES REVEALED A SMALL LEAK IN THE TUBING JUST ABOVE THE INSERTION POINT IN THE PGE TUBE. THE LINE WAS CHANGED, AND THE PATIENT'S SATURATION IMPROVED BACK TO THE 80'S. THERE WAS NO REPORT OF LASTING HARM, AND THE CUSTOMER STATED THEY BELIEVE THE PATIENT IMPROVED ONCE THE DOSE WAS AGAIN REGULATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A NICU PATIENT WAS RECEIVING 0.025 MCG/KG/MINUTE OF ALPROSTADIL (PGE) WHEN THEIR OXYGEN LEVEL BEGAN DE-SATURATING TO THE LOW 70'S. TRACING THE LINES REVEALED A SMALL LEAK IN THE TUBING JUST ABOVE THE INSERTION POINT IN THE PGE TUBE. THE LINE WAS CHANGED, AND THE PATIENT'S SATURATION IMPROVED BACK TO THE 80'S. THERE WAS NO REPORT OF LASTING HARM, AND THE CUSTOMER STATED THEY BELIEVE THE PATIENT IMPROVED ONCE THEIR DOSE WAS AGAIN REGULATED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NICU PATIENT WAS RECEIVING 0.025 MCG/KG/MINUTE OF ALPROSTADIL (PGE) WHEN THEIR OXYGEN LEVEL BEGAN DE-SATURATING TO THE LOW 70'S. TRACING THE LINES REVEALED A SMALL LEAK IN THE TUBING JUST ABOVE THE INSERTION POINT IN THE PGE TUBE. THE LINE WAS CHANGED, AND THE PATIENT'S SATURATION IMPROVED BACK TO THE 80'S. THERE WAS NO REPORT OF LASTING HARM, AND THE CUSTOMER STATED THEY BELIEVE THE PATIENT IMPROVED ONCE THEIR DOSE WAS AGAIN REGULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680798 MICROBORE EXTENSION SET, IV CONNECTOR,.F SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION MZ9226 10885403240621

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MZ5309| PRI TUBING,MZ1000-07,8015,8100, TD (B)(6) 2018| PRI TUBING,MZ1000-07,8015,8100, TD (B)(6) 2018