BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALITY EXTENSION SET

    MDR report key: 7844584 · Received September 4, 2018

    Report

    Report Number
    9616066-2018-01564
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 19, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403234866
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORT THAT THE SET LEAKED AT THE FILTER WAS NOT CONFIRMED. VISUAL INSPECTION OF THE SET SHOWED NO OBVIOUS DAMAGES OR ISSUES. FUNCTIONAL TESTING RESULTED IN NO LEAKS OR OTHER ISSUES. THE ROOT CAUSE OF THE REPORTED LEAK WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING AN INFUSION OF "PGE'S, D.25 1/4NS WITH KCL 4 1/2:1 H2O, WITH 0.05ML PGE/LINE OF IVF", THERE WAS A LEAK AT THE FILTER. NEW IVF'S WERE ORDERED. THERE WAS NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN INFUSION OF "PGE'S, D.25 1/4NS WITH KCL 4 1/2:1 H2O, WITH 0.05ML PGE/LINE OF IVF", THERE WAS A LEAK AT THE FILTER. NEW IVF'S WERE ORDERED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685147 SPECIALITY EXTENSION SET SET,EXTENSION,INTRAVASCULAR FPA CAREFUSION 20029E 10885403234866

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO 8100,PRI TUBING,8015, TD (B)(6) 2018