BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2962979 · Received January 23, 2013

    Report

    Report Number
    9616066-2013-00027
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID FREE FLOW DUE TO SPLIT IV TUBING. THE NURSE PUT THE TUBING BACK TOGETHER AND THE LEAK STOPPED. THE LOCATION OF THE SPLIT WAS NOT PROVIDED. THE TUBING WAS REPLACED AND THE TUBING AND THE PUMP WERE SENT TO THE BIOMED DEPARTMENT. DURING THEIR OWN INVESTIGATION, THE CUSTOMER WAS ABLE TO EASILY PULL APART THE SET AT THE UPPER FITMENT OF THE SILICONE SEGMENT. NO PT HARM OR MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33327 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

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