BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3788066 · Received January 8, 2014

    Report

    Report Number
    9616066-2013-01048
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Report Date
    December 9, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    SET RECEIVED UNEXPECTEDLY WITH THE RETURN FOR ANOTHER COMPLAINT. ONLY A PARTIAL SET WAS RECEIVED CONTAINING THE Y-BODY WITH SMARTSITE AND SIX INCHES OF TUBING ON EITHER SIDE. THE SET WAS RECEIVED WITH THE FOLLOWING NOTE: "HEY GIRLS, THIS IS THE Y-PORT SITE FROM ALARIS TUBING. WHEN LIZ PUT THE SYRINGE ON THE BLUE PORT STAYED IN AND FLUID FLOWED OUT AT HER. DIDN'T KNOW IF YOU WANTED IT. THANKS (B)(6)". THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION REQUIRED. THE CUSTOMER STATED THAT THE USER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14655 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SYRINGE: MFR/MODEL/LOT UNK