BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3940585 · Received April 18, 2014

    Report

    Report Number
    2016493-2014-00193
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 21, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED. THE PCU EVENT LOG, DATA SET, PUMP MODULE, AND TUBING HAVE BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT WAS RECEIVING CHEMOTHERAPY IN AN OUTPATIENT INFUSION CENTER. THE CUSTOMER REPORTED THAT "CHEMO COMPLETED EARLY AND TURNED TO FLUSH." ALTHOUGH THE CUSTOMER'S REVIEW OF THE LOG SHOWS THAT THE INFUSION WAS CORRECTLY PROGRAMMED, TO INFUSE AT A RATE OF 314.3 ML/HR WITH A VTBI OF 1050 ML, PLUS A 50 ML FLUSH AFTER THE CHEMO, ALL WOULD HAVE BEEN INFUSED IN 3.5 HOURS. HOWEVER, THE ENTIRE INFUSION COMPLETED IN LESS THAN 3 HOURS. THERE WAS NO HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238504 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR ALARIS PC UNIT SN (B)(4)| THERAPY DATE| ALARIS PUMP MODULE ADMIN SET 2110-0500/LOT UNK