BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SET

    MDR report key: 3851378 · Received March 26, 2014

    Report

    Report Number
    9616066-2014-00307
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Report Date
    March 13, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER REPORTED "WE JUST PULLED A PRIMARY TUBING OUT OF A PUMP AND IT HAS A ANEURYSM-LIKE DEFORMITY." THERE WAS NO REPORT OF HARM TO PT OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176846 ALARIS PUMP MODULE SET UNK FRN CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT| PUMP MODULE, SNS UNK, THERAPY DATE UNK