BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3883780 · Received February 12, 2014

    Report

    Report Number
    2016493-2014-00099
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    January 31, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94013 ALARIS PCA MODULE FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN (B)(4)| MODEL UNK, LOT UNK| PCA ADMINISTRATION SET, MANUFACTURER,