BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2632358 · Received June 18, 2012

    Report

    Report Number
    9616066-2012-00430
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Date of Event
    May 5, 2012
    Report Date
    May 24, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2012. (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WETNESS COMING FROM THE PUMP. PUMP STARTED TO KEEP OCCLUSION. OCCURRED IN THE ONCOLOGY CLINIC-KHO. DRUG INFUSING WAS CARBOPLATIN. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10013361 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT: S/N UNKNOWN| ALARIS PUMP MODULE: S/N UNKNOWN