BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PCU

    MDR report key: 9670727 · Received February 5, 2020

    Report

    Report Number
    2016493-2020-00172
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 15, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALARIS PCU AND CONNECTED MODULES WERE REQUESTED TO BE RETURNED FOR EVALUATION, HOWEVER NO DEVICES WERE RETURNED AS THE CUSTOMER HAS IDENTIFIED / ATTRIBUTED THE ISSUE TO A USER ERROR. THE CUSTOMER PROVIDED A COPY OF THE PCU EVENT LOG ALONG WITH DETAILS PINPOINTING THE PRECISE DATE / TIME OF THE REPORTED ISSUE. A REVIEW OF THE PCU EVENT LOG IDENTIFIED THAT THE PCU WAS INITIALLY POWERED ON WITH ONE PUMP MODULE ATTACHED (S/N (B)(4)) ON (B)(6) 2020 AT 22:07:45, THAT A SECOND PUMP MODULE (S/N (B)(4)) WAS ATTACHED TO THE PCU ON (B)(6) 2020 22:33:04 AND THAT THE PCU WAS POWERED OFF ON (B)(6) 2020 AT 14:00:26. DURING THIS PERIOD OF ACTIVITY BOTH PUMP MODULES WERE ACTIVE, HOWEVER WITHOUT THE PCU MODULE IT IS NOT POSSIBLE TO DETERMINE THE DRUG SELECTION AT THE START OF EACH INFUSION. THE REPORTED DATE / TIME OF THE ISSUE WAS PROVIDED AS (B)(6) 2020 10:00:00 AND A FURTHER REVIEW OF THE PCU EVENT LOG IDENTIFIED THE FOLLOWING SEQUENCE OF EVENTS RELATED TO THE REPORTED FEEDBACK AND PUMP MODULE S/N (B)(4) (SEE APPENDIX 1): (B)(6) 2020 03:49:46 PUMP MODULE (B)(4) CHANNEL OFF. (B)(6) 2020 09:59:59 PUMP MODULE (B)(4) CHANNEL SELECTED. (B)(6) 2020 10:00:00 PUMP MODULE (B)(4) BASIC INFUSION SELECTED. (B)(6) 2020 10:00:06 PUMP MODULE (B)(4) VTBI OF 223.0ML ENTERED. (B)(6) 2020 10:00:13 PUMP MODULE (B)(4) RATE OF 115.0ML/H ENTERED. (B)(6) 2020 10:00:14 PUMP MODULE (B)(4) INFUSION STARTED AT 115.0ML/H (VI = 587.45ML). (B)(6) 2020 10:00:15 PUMP MODULE (B)(4) ALARMED DOWNSTREAM OCCLUSION. (B)(6) 2020 10:00:19 PUMP MODULE (B)(4) INFUSION RESTARTED (VI = 587.45ML). (B)(6) 2020 10:01:10 PUMP MODULE (B)(4) ALARMED UPSTREAM OCCLUSION. (B)(6) 2020 10:01:15 PUMP MODULE (B)(4) INFUSION RESTARTED (VI = 589.014ML). (B)(6) 2020 11:32:45 PUMP MODULE (B)(4) INFUSION PAUSED (VI = 764.357ML). (B)(6) 2020 11:33:03 PUMP MODULE (B)(4) CHANNEL OFF. THIS INVESTIGATION HAS NOT CONFIRMED THE REPORTED RATE ACCURACY DISCREPANCY AS THE EVENT LOG IDENTIFIED THAT THE INFUSION WAS PAUSED AFTER AN INFUSION TIME OF 1 HOUR & 32 MINUTES AND NOT THE 1 HOUR STATED IN THE FEEDBACK. THE EVENT LOG ALSO IDENTIFIED THAT A TOTAL OF 176.907ML (764.357ML MINUS 587.45ML) WAS INFUSED DURING THIS TIME WHICH RESULTS IN 56.093ML OF THE PROGRAMMED VTBI (223.0ML) REMAINING WHICH CORRESPONDS WITH THE CUSTOMER FEEDBACK THAT THE BAG WAS ALMOST EMPTY WITH APPROXIMATELY 50ML REMAINING.

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTS THAT THERE WAS AN OVERINFUSION. ACCORDING TO THE REPORT SUBMITTED, PATIENT HAD A REACTION TO BLOOD TRANSFUSION, NO FURTHER DETAILS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135494 ALARIS SYSTEM PCU PUMP, INFUSION FRN CAREFUSION ALARIS PCU

    Patients

    Seq Age Sex Outcome Treatment
    1 (2) ALARIS LVP, THERAPY DATE UNKNOWN