BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8984472 · Received September 10, 2019

    Report

    Report Number
    2016493-2019-01149
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 11, 2019
    Report Date
    August 12, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH REQUESTED, THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION. B3: 8/10 2100 THROUGH 8/11 1100.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF AN OVER INFUSION COULD NOT BE CONFIRMED AS NO DEVICES WERE PROVIDED FOR THIS INVESTIGATION. THE CUSTOMER PROVIDED A PHOTO OF THE PUMP MODULE THAT APPEARS TO HAVE EXTRANEOUS MATERIAL BLOCKING THE PUMPING MECHANISM AND PRESSURE SENSORS, BASED ON THE IMAGE PROVIDED IT WAS DETERMINED THAT SUCH BLOCKAGE MAY CAUSE OVER INFUSION. THE CAUSE OF THE CUSTOMER'S REPORTED EXPERIENCE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CHEMO INFUSION OVER THE WEEKEND, THE DEVICE OVER INFUSED OVER 14 HOURS INSTEAD OF 24 HOURS. THE CHEMO (CISPLATIN/CYCLOPHOSPHAMIDE/ETOPOSIDE IN 500 ML NS AT 24.5 ML/HOUR) WAS SUPPOSED CHARTED AS STARTED 8/10 2101 AND WAS REPORTED TO RUN OUT AROUND 1100 8/11 INSTEAD OF 2100. THERE WAS NO HARM OR ISSUE WITH THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CHEMOTHERAPY INFUSION, THE DEVICE INFUSED IN 14 HOURS INSTEAD OF 24 HOURS. CISPLATIN IN 500 ML NS AT 24.5 ML/HOUR WAS INITIATED 8/10/19 AT 2101 AND THE INFUSION COMPLETED ON 8/11/19AT 1100 INSTEAD OF 2100. THERE WAS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION. DATE OF EVENT: (B)(6) 2100 THROUGH (B)(6) 1100.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHEMO INFUSION OVER THE WEEKEND, THE DEVICE OVER INFUSED OVER 14 HOURS INSTEAD OF 24 HOURS. THE CHEMO (CISPLATIN/CYCLOPHOSPHAMIDE/ETOPOSIDE IN 500 ML NS AT 24.5 ML/HOUR) WAS SUPPOSED CHARTED AS STARTED 8/10 2101 AND WAS REPORTED TO RUN OUT AROUND 1100 8/11 INSTEAD OF 2100. THERE WAS NO HARM OR ISSUE WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777804 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male 8100,8015, (2)PRI TUBING, THERAPY DATE: (B)(6) 1100.