BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3620136 · Received October 29, 2013

    Report

    Report Number
    9616066-2013-00837
    Event Type
    Malfunction
    Date Received
    October 29, 2013
    Report Date
    October 10, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT DATE: (B)(4) 2013. INTERNAL FILE NO: (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

    THE CUSTOMER REPORTED 4-5 INSTANCES OF ALARIS SET #2420-0007 BECOMING DISCONNECTED OR "SPINNING OFF" OVER TIME WHEN CONNECTED TO A MF 1000-C CONNECTOR OR Q-STYLE CONNECTOR. THERE WAS NO PT HARM REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556011 ALARIS PUMP MODULE ADMIN SET FPA CAREFUSION CORP 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THERAPY DATE: UNK| Q-STYLE CONNECTOR: MFR/MODEL/LOT UNK,| MAXPLUS 1000C CONNECTOR: LOT UNK,