BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000096-1999-00080

    MDR report key: 257409 · Received December 22, 1999

    Report

    Report Number
    6000096-1999-00080
    Event Type
    Malfunction
    Date Received
    December 22, 1999
    Date of Event
    November 1, 1999
    Report Date
    December 6, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AIR IN SYRINGE IV TUBING REPORTED. IN #1 OF 2 INCIDENCES, THE CUSTOMER STATED THAT "TUBING USED WITH SYRINGE--AIR INFUSED REPEATEDLY POST CASSETTE." THE PT WAS RECEIVING AN UNSPECIFIED DOSE OF FENTANYL PER DRIP AT A RATE OF 1.8CC/HR. INFO REC'D FROM THE REPRESENTATIVE STATES THAT AN UNSPECIFIED AMOUNT OF AIR WAS BUILDING UP IN THE IV TUBING, AND MICROBUBBLES WERE NOTED IN THE SYRINGE WHEN ADMINISTERING A FENTANYL DRIP, BUT NOT WHEN ADMINISTERING TPN OR LIPIDS. NO NEGATIVE OUTCOME HAS BEEN REPORTED. THE CUSTOMER HAS INITIATED USE OF A VENTED SYRINGE ADAPTER TO SOLVE THIS PROBLEM. NO FURTHER REPORTS OF THIS NATURE HAVE BEEN REC'D. ADD'L INFO HAS BEEN REQUESTED, BUT NO FURTHER INFO HAS BECOME AVAILABLE. IF FURTHER INFO BECOMES AVAILABLE, IT WILL BE FORWARDED TO THE AGENCY.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 1. UNSPECIFIED PLUM XL PUMP.