BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2082576 · Received April 27, 2011

    Report

    Report Number
    9616066-2011-00153
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    April 3, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/27/2011. (B)(4). PRODUCT IS EXPECTED BACK FROM THE CUSTOMER FOR EVAL BUT HAS NOT BEEN RECEIVED YET. A F/U REPORT WILL BE SUBMITTED ONCE THE SET HAS BEEN RECEIVED AND AN INVESTIGATION HAS BEEN PERFORMED OR ADD'L INFO IS OBTAINED.

    Description of Event or Problem · 1

    RECEIVED REPORT OF BALLOONED SILICONE SEGMENT. THERE WAS NO REPORT OF PT OR USER HARM. NO ADD'L INFO WAS PROVIDED. CUSTOMER IS RETURNING SET FOR EVAL.

    Devices

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

    Patients

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