BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3043425 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00166
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF SET LEAKING AT THE MALE LUER COULD NOT BE CONFIRMED. THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKING AT THE MALE LUER LOCK CONNECTION DURING AN INFUSION. THE CUSTOMER FEELS THIS WAS A USER ISSUE BY NOT TIGHTENING THE MALE LUER LOCK TIGHT ENOUGH AND NO IV SET DEFAULT OCCURRED. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106200 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT, SN UNKNOWN| ALARIS PUMP MODULE, SN UNKNOWN