BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3941462 · Received April 16, 2014

    Report

    Report Number
    9616066-2014-00370
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER STATED THE TUBING WILL NOT BE RETURNED BECAUSE THE TUBING WAS NOT SEQUESTERED. CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SECONDARY INFUSION COMPLETED TOO QUICKLY. PIPERACILLIN/TAZOBACTAM 3.375 GM IN 50ML D5W WAS PROGRAMMED TO INFUSE OVER 4 HOURS, AT 12/5ML/HR VIA A CENTRAL LINE. TH ERN NOTICED APPROXIMATELY 15 MINUTES LATER THAT THE BAG WAS EMPTY AND THE SECONDARY TUBING WAS DRY. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232211 ALARIS PUMP MODULE ADMINISTRATION SET UNK FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PCA MODULE: SN (B)(4)| PCA ADMIN SET: MFR/MODEL/LOT UNK| PUMP MODULE ADMIN SET: MFR/MODEL LOT UNK| ALARIS PUMP MODULE: SN (B)(4)| CENTRAL LINE: MR/MODEL/LOT UNK| ALARIS PUMP MODULE: SN (B)(4)