BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHASEAL INFUSION ADAPTER

    MDR report key: 1184217 · Received October 2, 2008

    Report

    Report Number
    9615998-2008-00005
    Event Type
    Other
    Date Received
    October 2, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 29, 2008
    Manufacturer
    CARMEL PHARMA AB.
    Product Code
    LHI
    PMA / PMN Number
    K023747
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION SET WHICH WAS USED DURING THE INFUSION WAS CONFIRMED TO BE A VENTED SET. IT CAN NOT BE CONFIRMED WHETHER THE VENT WAS OPEN OR CLOSED AT THE TIME OF THE INCIDENT. BASED ON THE AVAILABLE INFORMATION AND FOLLOW-UP PERFORMED TOGETHER WITH THE CUSTOMER, IT IS, HOWEVER, CONSIDERED MOST LIKELY THAT THE INFUSION VENT WAS OPEN DURING THE INFUSION. THE INSTRUCTION FOR USE OF THE PHASEAL INFUSION ADAPTER C100 STATES: "A NON-VENTED IV SET SHOULD BE USED TOGETHER WITH THE C100 INFUSION ADAPTER. IF A VENTED SET IS USED, MAKE SURE THAT THE AIR INLET IS CLOSED THROUGHOUT THE INFUSION PROCEDURE." RE-TRAINING AND ADDITIONAL INFORMATION HAVE BEEN PROVIDED TO THE CUSTOMER AS OF SEPTEMBER 3, 2008.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AIR WAS OBSERVED IN THE BRAUN INFUSION TUBING AS THE BRAUN INFUSION BAG WAS ALMOST EMPTIED. THE INFUSION PROCEDURE WAS PERFORMED THROUGH GRAVITY FEED. NO PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHASEAL INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET LHI CARMEL PHARMA AB. C100 715194

    Patients

    Seq Age Sex Outcome Treatment
    1