BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3883779 · Received February 12, 2014

    Report

    Report Number
    9616066-2014-00126
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    January 31, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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 THE DISTAL END OF THE TUBING BROKE OFF INTO THE PORT. THE CUSTOMER USES A CUROS PORT PROTECTOR ON THE CARESITE LUER ACCESS DEVICE AND DOES NOT ALLOW THE SURFACE OF THE ACCESS DEVICE TO DRY BEFORE INSERTION OF THE MALE LUER OF THE IV TUBING. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94280 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE, SN UNK| CUROS PORT PROTECTOR, MODEL/LOT UNK| END CAP, MANUFACTURE/MODEL/LOT UNK| B BRAUN CARESIT LUER ACCESS DEVICE, MODEL/LOT UNK