BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 9249759 · Received October 29, 2019

    Report

    Report Number
    2016493-2019-01389
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    August 20, 2019
    Report Date
    October 4, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S BSA = 2.2 THE UNITS ON THE PATIENT'S WEIGHT WERE NOT PROVIDED. THE CUSTOMER¿S REPORT OF AN INFUSION INFUSING LONGER THAN EXPECTED WAS CONFIRMED THROUGH FUNCTIONAL TESTING. THE PCU EVENT LOG CONTAINED NO OBVIOUS PROGRAMMING ERRORS THAT WOULD RESULT IN THE REPORTED EVENT. THE INFUSIONS WERE PROGRAMMED AS STATED IN THE EVENT DESCRIPTION VIA REMOTE IV REQUEST. A REVIEW OF THE DEVICE ERROR LOGS FOUND NO ERRORS DURING THE TIME PERIOD OF THE REPORTED EVENT. DISASSEMBLY OF THE DEVICE FOUND THE UPPER LEFT BEZEL BOSS POST SCREW INSERT WAS NOT COMPLETELY SEATED INTO THE BOSS, WHICH CAN EXPLAIN THE RATE INACCURACY ERROR. FUNCTIONAL TESTING FOUND THE DEVICE TO BE UNDERPERFUSING AND THE DEVICE WAS ABLE TO BE CALIBRATED, AND THEN WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT 0826 THE NURSE INITIATED A PRIMARY INFUSION OF CISPLATIN 44MG/MAGNESIUM SULFATE 3G/NACL 0.9% TO INFUSE AT A RATE OF 750.7ML/HOUR WITH A VTBI OF 1126ML AND A DURATION OF 1.5 HOURS. THE INFUSION WAS FOUND TO BE COMPLETED AT 1019, 23 MINUTES LONGER THAN EXPECTED. AT 1022, THE SAME DEVICES WERE PROGRAMMED FOR A PRIMARY INFUSION OF ETOPOSIDE 220MG/NACL 0.9% AT A RATE OF 728ML/HOUR WITH VTBI OF 1092ML FOR A DURATION OF 1.5 HOURS. AT 1212, THE DEVICE ALARMED INFUSION COMPLETED, HOWEVER, UPON ASSESSMENT THE NURSE FOUND THAT THERE WAS MEDICATION REMAINING IN THE IV BAG AND HAD TO MANUALLY PROGRAM ADDITIONAL VOLUME IN ORDER TO COMPLETE THE INFUSION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THE EVENT.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. PATIENT AGE AND DOB REQUESTED BUT NOT PROVIDED, HOWEVER, THE CUSTOMER STATED THAT THE PATIENT WAS AN ADULT PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 0826 THE NURSE INITIATED A PRIMARY INFUSION OF CISPLATIN 44MG/MAGNESIUM SULFATE 3G/NACL 0.9% TO INFUSE AT A RATE OF 750.7ML/HOUR WITH A VTBI OF 1126ML TO INFUSE OVER THE DURATION OF 1.5 HOURS. THE INFUSION WAS FOUND TO BE COMPLETED AT 1019 WITH THE INFUSION INFUSING 23 MINUTES LONGER THAN EXPECTED. AT 1022, THE SAME DEVICES WERE PROGRAMMED TO INFUSE A PRIMARY INFUSION OF ETOPOSIDE 220MG/NACL 0.9% AT A RATE OF 728ML/HOUR WITH VTBI OF 1092ML FOR THE DURATION OF 1.5 HOURS. AT 1212, THE DEVICE ALARMED INFUSION COMPLETED, HOWEVER, UPON ASSESSMENT THE NURSE FOUND THAT THERE WAS MEDICATION REMAINING IN THE IV BAG AND HAD TO MANUALLY PROGRAM ADDITIONAL VOLUME IN ORDER TO COMPLETE THE INFUSION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046279 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 (2)PRI TUBING,8015,8100, TD (B)(6) 2019