BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2940506 · Received December 19, 2012

    Report

    Report Number
    9616066-2012-00900
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    November 28, 2012
    Manufacturer
    CAREFUSION COROPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    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). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SET SNAPPED OFF AT THE FIRST SPLIT SEPTUM PORT. THERE WAS NO LEAKING OF SOLUTION AND NOTHING WAS CONNECTED TO THE PORT WHEN THE SET BROKE. THERE WAS NO INJECTION BEING PERFORMED DURING THE BREAK. NO REPORT OF PT OR STAFF HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION COROPORATION 2120-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK