BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3964843 · Received July 16, 2014

    Report

    Report Number
    2016493-2014-00358
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 07/16/2014. 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

    CUSTOMER REPORTED THAT THE DEVICE INFUSED TOO FAST. THE DEVICE WAS PROGRAMMED FOR A VTBI OF 250 ML TO INFUSE AT 10.4 ML/HR BUT THE BAG WAS EMPTY IN 2 HRS. CUSTOMER REPORTED THAT HE IDENTIFIED PROGRAMMING IN THE LOG CONSISTENT WITH THE REPORTED EVENT, AND TESTED THE MODULE AND FOUND IT TO BE OPERATING WITHIN SPECIFICATION. CUSTOMER IS REQUESTING ASSISTANCE WITH FURTHER INVESTIGATION. CUSTOMER'S INTERNAL REPORT STATES UNSPECIFIED HARM OCCURRED; ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415922 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

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