BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11671124 · Received April 15, 2021

    Report

    Report Number
    2016493-2021-502431
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 19, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    IT AS REPORTED THAT THE DEVICE WAS PROGRAMMED AT 8:50 PM TO INFUSE 448 ML/HOUR FOR A TOTAL OF 1790 ML OVER 4 HOURS, BUT DELIVERED AT THE WRONG RATE WITH A TOTAL OF 1820 ML BEING INFUSED. CUSTOMER THINKS THIS COULD BE A POSSIBLE UNDER DELIVERY. THIS EVENT HAPPENED IN THE ICU. NO PATIENT HARM. ALTHOUGH REQUESTED, FURTHER INFORMATION NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE REPORT OF AN UNDERINFUSION OF AN UNSPECIFIED MEDICATION WAS NOT REPRODUCED. LOG ANALYSIS RESULTS: THE PCU EVENT LOG REVIEW SHOWS PUMP MODULE S/N (B)(4) WAS PROGRAMMED TO INFUSE DRUGID 112 AT A RATE OF 448ML/HR WITH A VTBI OF 1790ML AT 8:50 PM ON (B)(6) 2021 AND THEN PROGRAMMED A DELAY FOR 3 MINUTES. AT 8:51 PM, THE USER CANCELLED THE DELAY AND STARTED THE INFUSION. (1790/448 ~ 4 HOURS, WHICH MEANS THE INFUSION WOULD COMPLETE AROUND 12:51 AM ON (B)(6) 2021) AT 8:57 PM, THE DEVICE ALARMED FOR PATIENT SIDE OCCLUSION AND THE USER RESTARTED THE INFUSION AT 9:01 PM. AT 9:01 PM, THE USER SELECTED THE DEVICE AND THEN RESTARTED THE INFUSION (THE DEVICE WAS IN THE ALARM STATE FOR 3 MINUTES AND 37 SECONDS). AT 12:53 AM ON (B)(6) 2021, THE USER CHANGED THE VTBI TO 300ML AND STARTED THE INFUSION.(THE INFUSION WAS STARTED AT 8:51 PM AND SHOULD HAVE COMPLETED AT 12:51 AM, HOWEVER SINCE THE DEVICE WAS IN AN ALARM STATE, AND NOT INFUSING FOR 3 MINUTES AND 37 SECONDS, THE NEW INFUSION COMPLETED TIME IS BETWEEN 12:54 AM AND 12:55 AM. THE VOLUME THAT WOULD HAVE BEEN DELIVERED DURING THIS ¿ALARMED¿ TIME FRAME WAS 26.85ML. AT 12:59 AM, THE USER PAUSED THE INFUSION. ONE SECOND LATER THE USER RESTARTED THE INFUSION BUT PAUSED THE INFUSION AGAIN AFTER ONLY 4 SECONDS. AT 1:00 AM, THE USER CHANNELED OFF THE DEVICE. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 1820.34ML. A REVIEW OF THE DEVICE ERROR LOGS FOUND NO ERRORS DURING THE TIME OF THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED UNDERINFUSION OF AN UNSPECIFIED MEDICATION WAS NOT IDENTIFIED. THE CUSTOMER¿S REPORT THAT 1820MLNFUSED INSTEAD OF THE PROGRAMMED 1790ML WOULD EQUATE TO AN ERROR OF 1.67 % WHICH IS WELL WITHIN THE +/-5% SPECIFICATION OF THE DEVICE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 09 AUGUST 2013. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR PUMP MODULE S/N (B)(4) 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)(4) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 1

    IT AS REPORTED THAT THE DEVICE WAS PROGRAMMED AT 8:50 PM TO INFUSE 448 ML/HOUR FOR A TOTAL OF 1790 ML OVER 4 HOURS, BUT DELIVERED AT THE WRONG RATE WITH A TOTAL OF 1820 ML BEING INFUSED. CUSTOMER THINKS THIS COULD BE A POSSIBLE UNDER DELIVERY. THIS EVENT HAPPENED IN THE ICU. NO PATIENT HARM. ALTHOUGH REQUESTED, FURTHER INFORMATION NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573568 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 8015| PRI TUBING| 8015| PRI TUBING