BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11175406 · Received January 14, 2021

    Report

    Report Number
    2016493-2021-05738
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 18, 2020
    Report Date
    December 21, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO: REVISED SHORT DESCRIPTION, ADDED END USER, ADDED DATE AND TIME OF EVENT. REVISED B5, G3. ADDED A1, A2 AND A3. ESTIMATED PATIENT'S APPROXIMATE AGE TO BE 73 AT THE TIME OF THE EVENT BASED ON THE DATE OF THE EVENT AND THE PATIENTS DATE OF BIRTH.

    Additional Manufacturer Narrative · 0

    THIS LVP (8100) (B)(6) IS NO LONGER CONSIDERED A SOURCE INSTRUMENT. THE LVP (8100) (B)(6) IS NOW THE SUSPECT DEVICE. BSA 1.68M2. FI COMPLETE. THE CUSTOMERS REPORTED ISSUE OF IRINOTECAN INFUSING IN 2 HOURS AND 5 MINUTES INSTEAD OF 1 HOUR AND 30 MINUTES WAS NOT REPRODUCED DURING TESTING. FUNCTIONAL TESTING PERFORMED ON THE RETURNED PUMP MODULE OBSERVED THE DEVICE TO BE IN SPECIFICATION FOR RATE ACCURACY. NO ERRORS OR MALFUNCTIONS WERE RECORDED ON THE REPORTED INCIDENT DATE OF 18 DECEMBER 2020. THE PCU DEVICE AND PUMP MODULES EVENT LOG DOES NOT SHOW THE DEVICE IN USE ON THE REPORTED INCIDENT DATE OF 18 DECEMBER 2020. SAMPLE INSPECTION: THE PUMP MODULE (B)(6) WAS RECEIVED WITH INSTRUMENT SEAL INTACT. THE UPPER FITMENT RECESS WAS OBSERVED TO BE DAMAGED. INTERNAL INSPECTION OBSERVED NO SIGNS OF FLUID INGRESS AND THE ELECTRICAL AND MECHANICAL COMPONENTS WERE OBSERVED WITH NO ANOMALIES. LOG ANALYSIS RESULTS: NO ERRORS OR MALFUNCTIONS WERE RECORDED ON THE REPORTED INCIDENT DATE OF 18 DECEMBER 2020. THE PCU DEVICE AND PUMP MODULES EVENT LOG DOES NOT SHOW THE DEVICE IN USE ON THE REPORTED INCIDENT DATE OF 18 DECEMBER 2020. AN INFUSION OCCURRED ON 07 DECEMBER THAT MATCHES THE CUSTOMER REPORTED DRUG, RATE, AND VTBI. ON 07 DECEMBER 2020 AT 4:32 PM PUMP MODULE (B)(6) WAS PROGRAMMED AS GUARDRAILS DRUG WITH THE FOLLOWING PARAMETERS: IRINOTECAN (DRUG ID 311), BSA 1.68M2, DRUG AMOUNT 240MG, DILUENT 512ML, DOSE 142.9MG/M2, CONCENTRATION 0.469MG/ML, RATE 341.3ML/H, VTBI 512 AND INFUSION WAS PAUSED. USER CHANGES VTBI TO 550ML AND THE INFUSION WAS STARTED. PVI AT THE TIME 0.6ML. AT 6:02 PM THE PUMP MODULE WAS SELECTED FOR PROGRAMMING AND VTBI 150ML ARE ENTERED AND INFUSION WAS STARTED. PVI AT THE TIME 503.3ML. AT 6:28 PM THE INFUSION WAS COMPLETED. PVI AT THE TIME 653.4ML AT 6:28 PM THE PUMP MODULE WAS SELECTED FOR PROGRAMMING AND VTBI 100ML ARE ENTERED AND INFUSION WAS STARTED. PVI AT THE TIME 653.4ML. AT 6:34 PM THE PUMP MODULE ALARMED FOR AIR IN LINE ONE MINUTE LATER THE MODULE WAS CHANNELED OFF. PVI AT THE TIME 685.9ML. TEST RESULTS: FUNCTIONAL TESTING AND TIMED RATE ACCURACY TEST WAS PERFORMED ON THE RETURNED PUMP MODULE AND THE DEVICE WAS FOUND TO BE IN SPECIFICATION FOR RATE ACCURACY. ROOT CAUSE: THE ROOT CAUSE OF THE CUSTOMERS COMPLAINT OF AN UNDER INFUSION OF IRINOTECAN WAS NOT DEFINITELY DETERMINED. HOWEVER, DAMAGED WAS OBSERVED ON THE FITMENT RECESS CONSISTENT WITH SET MISLOAD THAT MAY AFFECT RATE ACCURACY (REDUCTION IN FLOW RATE ACCURACY).

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE LCI UNIT THAT THE IRINOTECAN MEDICATION WAS PROGRAMMED ON CHANNEL B VIA SHORT SET TO INFUSE AT A RATE OF 341ML/HOUR FOR A VOLUME TO BE INFUSED OF 512ML WITH A DURATION OF 1 HOUR AND 30 MINUTES, HOWEVER THE DEVICE TOOK 2 HOURS AND 5 MINUTES TO INFUSE THE MEDICATION. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE LCI UNIT THAT THE IRINOTECAN MEDICATION WAS PROGRAMMED ON CHANNEL B VIA SHORT SET TO INFUSE AT A RATE OF 341ML/HOUR FOR A VOLUME TO BE INFUSED OF 512ML WITH A DURATION OF 1 HOUR AND 30 MINUTES, HOWEVER THE DEVICE TOOK 2 HOURS AND 5 MINUTES TO INFUSE THE MEDICATION. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

    Additional Manufacturer Narrative · 1

    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. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TOOK LONGER THAN EXPECTED TO INFUSE A PROGRAMMED UNSPECIFIED MEDICATION. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71309 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1