BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17246042 · Received July 3, 2023

    Report

    Report Number
    2016493-2023-190092
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 31, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403812002
    PMA / PMN Number
    K043299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3 OTHER TEXT : NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-190092 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER2016493-2023-190840, 2016493-2023-190089, 2016493-2023-190093 WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVIEW OF THE ALL INFUSION DETAIL REPORT REVEALED A DISCREPANCY ON THE PCA MODULE LOCKOUT INTERVAL PROGRAMMING, THE ORDER WAS HYDROMORPHONE (DILAUDID) 1MG/ML PCA, PATIENT BOLUS: 0.2MG, LOCKOUT INTERVAL: 10 MINUTES, CONTINUOUS DOSE: 0MG/HR, ONE HOUR DOSE LIMIT: 1.5MG, AND LOADING DOSE: 0.2MG. HOWEVER, THE REPORT STATES THAT A "6-MINUTE LOCKOUT INTERVAL" HAD BEEN PROGRAMMED. THE REPORT ALSO SHOWED THAT 0.2 MG OF A LOADING DOSE WAS DELIVERED AND AN ADDITIONAL 1 MG OF PCA DOSE DELIVERED OVER THE DURATION OF THIS PCA INFUSION. IT WAS DOCUMENTED IN THE ELECTRONIC MEDICAL RECORD (EMR) THAT ABOUT 26ML OF DRUG WAS DISCARDED FROM A 50ML SYRINGE. THE EMR ALSO SHOWED THAT THE SCHEDULED START DATE/TIME WAS "(B)(6)23 1415" AND END DATE/TIME WAS "(B)(6)23 1923." THE CUSTOMER IS REQUESTING BD TO FIND OUT THE FOLLOWING THROUGH REVIEW OF THE DEVICE LOGS: WHAT WAS THE SYRINGE SELECTED? WHAT WAS THE VOLUME ASSESSED IN THE SYRINGE AT THE START AND AT THE END? WAS PRIMING USED FOR THIS PCA? ARE THERE ANY ETCO2 ALARMS THAT FIRED? WAS THE INFUSION SHUT OFF AT ALL DURING THE DURATION OF DELIVERY? THERE WAS PATIENT INVOLVEMENT, BUT IT IS UNKNOWN IF THERE WAS HARM. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVIEW OF THE ALL INFUSION DETAIL REPORT REVEALED A DISCREPANCY ON THE PCA MODULE LOCKOUT INTERVAL PROGRAMMING, THE ORDER WAS HYDROMORPHONE (DILAUDID) 1MG/ML PCA, PATIENT BOLUS: 0.2MG, LOCKOUT INTERVAL: 10 MINUTES, CONTINUOUS DOSE: 0MG/HR., ONE HOUR DOSE LIMIT: 1.5MG, AND LOADING DOSE: 0.2MG. HOWEVER, THE REPORT STATES THAT A "6-MINUTE LOCKOUT INTERVAL" HAD BEEN PROGRAMMED. THE REPORT ALSO SHOWED THAT 0.2 MG OF A LOADING DOSE WAS DELIVERED AND AN ADDITIONAL 1 MG OF PCA DOSE DELIVERED OVER THE DURATION OF THIS PCA INFUSION. IT WAS DOCUMENTED IN THE ELECTRONIC MEDICAL RECORD (EMR) THAT ABOUT 26ML OF DRUG WAS DISCARDED FROM A 50ML SYRINGE. THE EMR ALSO SHOWED THAT THE SCHEDULED START DATE/TIME WAS "06/07/23 1415" AND END DATE/TIME WAS "06/07/23 1923." THE CUSTOMER IS REQUESTING BD TO FIND OUT THE FOLLOWING THROUGH REVIEW OF THE DEVICE LOGS: WHAT WAS THE SYRINGE SELECTED? WHAT WAS THE VOLUME ASSESSED IN THE SYRINGE AT THE START AND AT THE END? WAS PRIMING USED FOR THIS PCA? ARE THERE ANY ETCO2 ALARMS THAT FIRED? WAS THE INFUSION SHUT OFF AT ALL DURING THE DURATION OF DELIVERY? THERE WAS PATIENT INVOLVEMENT, BUT IT IS UNKNOWN IF THERE WAS HARM. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED. BD LEARNED ADDITIONAL INFORMATION FROM THE CUSTOMER, WHO REPORTED THAT THEY'VE CONDUCTED THEIR OWN ANALYSIS OF THE DEVICE LOGS AND PROVIDED THE FOLLOWING INFORMATION: PUMP HAD THE LATEST DATASET PUMP WAS ON GUARDRAILS PROGRAMMING MATCHED THE PCA ORDER AT THE TIME THE PUMP WAS PROGRAMMED AT 14:10 O LOCKOUT 6 MIN, PCA DOSE 0.2MG, LOADING DOSE 0.2MG, ONE HR. DOSE LIMIT 2MG TOTAL OF 1.2MG HYDROMORPHONE WAS GIVEN OVER THE SPAN OF 2 HOURS O 1410 LOADING DOSE 0.2MG; O 1421 1ST PCA DOSE 0.2MG; O 1432 2ND PCA DOSE 0.2MG; O 1553 3RD PCA DOSE 0.2MG; O 1601 4TH PCA DOSE 0.2MG; O 1610 5TH PCA DOSE 0.2MG. THE ORDER WAS CHANGED AT 1656 AND VERIFIED AT 1658 FOR LOCKOUT 10MIN, ONE HR. DOSE LIMIT 1.5MG. THE CUSTOMER IS REQUESTING BD TO ASSIST WITH REVIEWING THE LOGS AND ANSWER THE FOLLOWING QUESTIONS: 1. WHAT SYRINGE WAS SELECTED DURING SETUP? 2. WAS THE ETCO2 MODULE FUNCTIONING (PAUSED 3 TIMES) AND WERE THERE ANY ETCO2 ALARMS THAT FIRED? 3. WHAT WAS THE VOLUME INFUSED? A. 50ML DISPENSED. B. 1.2 ML GIVEN. C. 26 ML WASTED PER RN NOTE AT 4:44PM D. 22.8 ML UNACCOUNTED FOR, OF WHICH SOME WOULD BE USED FOR PRIMING AND POSSIBLY NOTED IN THE KEYSTROKE LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21649 ALARIS SYSTEM PUMP, INFUSION MEA CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown