BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3821572 · Received January 15, 2014

    Report

    Report Number
    2016493-2014-00062
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 28, 2013
    Report Date
    December 30, 2013
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT DATE: 01/15/2014. INTERNAL FILE NO: (B)(4). THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. NEITHER THE EVENT LOGS NOR THE DEVICES HAVE BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE LOGS OR DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION. THE CUSTOMER WOULD NOT PROVIDE ANY SPECIFIC DETAILS AND THEY'RE NOT SURE WHICH PUMP MODULE THE OVER INFUSION OCCURRED ON. THE CUSTOMER REQUESTS AN EVENT LOG REVIEW FOR PROGRAMMING, ALARMS, AND VOLUME INFUSED FROM (B)(6) 2013 AT 0100 TO (B)(6) 2013 AT 0600 ON BOTH PUMP MODULES THAT WERE CONNECTED TO THE PT. THE CUSTOMER ALSO REQUESTS AN INVESTIGATION THAT THE DEVICES ARE FUNCTIONING PROPERLY. THERE WAS NO PT HARM OR MEDICAL INTERVENTION REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40528 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PUMP MODULE ADMIN SETS, MODEL/LOT UNK