BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11518007 · Received March 18, 2021

    Report

    Report Number
    2016493-2021-29617
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 14, 2021
    Report Date
    February 23, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT OF A CYTARABINE INFUSION THAT RAN SLOW WAS NOT REPRODUCED DURING THE INVESTIGATION. LOG ANALYSIS RESULTS: THE PCU EVENT LOG SHOWS PUMP MODULE S/N (B)(6) WAS PROGRAMMED TO INFUSE A CUSTOM CONCENTRATION INFUSION OF DRUGID 140 TO INFUSE AT A RATE OF 13ML/HR WITH A VTBI OF 110ML AT 7:54 PM ON (B)(6) 2021. AT THESE PARAMETERS, THE INFUSION WOULD COMPLETE IN APPROXIMATELY 8.5 HOURS. (ENDING AROUND 4:26 AM). AT 8:05 PM, THE DEVICE ALARMED FOR AIR IN LINE AND THE INFUSION WAS RESTARTED AT 8:06 PM. AT 12:39 AM ON (B)(6) 2021, THE DEVICE AGAIN ALARMED FOR AIR IN LINE AND THE INFUSION WAS RESTARTED 40 SECONDS LATER. AT 4:19 AM, THE USER CHANGED THE VTBI TO 20ML. AT 5:18 AM, THE USER CHANGED THE RATE TO 26ML/HR AND STARTED THE INFUSION. AT 5:27 AM, THE USER CHANGED THE VTBI TO 45ML AND STARTED THE INFUSION AT 6:35 AM, THE USER CHANGED THE VTBI TO 20ML AND STARTED THE INFUSION. AT 7:15 AM, THE DEVICE ALARMED FOR AIR IN LINE. AT 7:19 AM, THE DEVICE WAS CHANNELED OFF AND THE SYSTEM WAS SHUTDOWN AND POWERED OFF. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 172.427ML. A REVIEW OF THE PCU ERROR LOG FOUND NO ERRORS DURING THE TIME OF THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED CYTARABINE INFUSION THAT RAN SLOW WAS NOT IDENTIFIED. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 09 FEBRUARY 2016. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR PUMP MODULE S/N (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE PUMP MODULE S/N (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. NO DEVICE RECEIVED-LOG REVIEW ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN REGISTERED NURSE (RN) ENTERED THE PATIENT'S ROOM DURING NIGHT SHIFT AROUND 0500 TO ADMINISTER THE NS FLUSH FOR PATIENT'S 12 HOUR CYTARABINE INFUSION (2000-0800), THE BAG HAD ABOUT AN EXTRA 15ML OF FLUID LEFT. THE INFUSION WAS RUNNING AT 13ML/HR/ THIS WOULD CAUSE THE INFUSION TO GO OVER ABOUT 1-2 HOURS. THE PATIENT'S CHEMOTHERAPY ORDERS HAS A BAG OF CYTARABINE DUE AT HOUR 12 (0800). THE DOCTOR INSTRUCTED RN TO DOUBLE THE RATE TO 26 ML/HR IN ORDER FOR THE CHEMO TO FINISH IN TIME FOR THE SECOND BAG TO BE HUNG. THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN REGISTERED NURSE (RN) ENTERED THE PATIENT'S ROOM DURING NIGHT SHIFT AROUND 0500 TO ADMINISTER THE NS FLUSH FOR PATIENT'S 12 HOUR CYTARABINE INFUSION (2000-0800), THE BAG HAD ABOUT AN EXTRA 15ML OF FLUID LEFT. THE INFUSION WAS RUNNING AT 13ML/HR/ THIS WOULD CAUSE THE INFUSION TO GO OVER ABOUT 1-2 HOURS. THE PATIENT'S CHEMOTHERAPY ORDERS HAS A BAG OF CYTARABINE DUE AT HOUR 12 (0800). THE DOCTOR INSTRUCTED RN TO DOUBLE THE RATE TO 26 ML/HR IN ORDER FOR THE CHEMO TO FINISH IN TIME FOR THE SECOND BAG TO BE HUNG. THERE WAS NO REPORTED PATIENT HARM.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. NO DEVICE RECEIVED-LOG REVIEW ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN REGISTERED NURSE (RN) ENTERED THE PATIENT'S ROOM AROUND 0500 TO ADMINISTER THE NS FLUSH FOR PATIENT'S 12 HOUR CYTARABINE INFUSION (2000-0800), THE BAG HAD ABOUT AN EXTRA 15ML OF FLUID LEFT. THE INFUSION WAS RUNNING AT 13 ML/HR/ THIS WOULD CAUSE THE INFUSION TO GO OVER ABOUT 1-2 HOURS. THE PATIENT'S CHEMOTHERAPY ORDERS HAS A BAG OF CYTARABINE DUE AT HOUR 12 (0800). THE DOCTOR INSTRUCTED RN TO DOUBLE THE RATE TO 26 ML/HR IN ORDER FOR THE CHEMO TO FINISH IN TIME FOR THE SECOND BAG TO BE HUNG. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413745 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR 8015| 8110| PRI TUBING| SYR TUBE