ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-18140
- Event Type
- Malfunction
- Date Received
- March 6, 2024
- Date of Event
- November 20, 2023
- Report Date
- September 23, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- MEA
- UDI-DI
- 10885403812033
- PMA / PMN Number
- K043299
- Removal / Correction Number
- Z-2720-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
OMIT: G0405206 - LATCH, C070606 - WEAR PROBLEM, D02 - CAUSE TRACED TO COMPONENT FAILURE. CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)#. ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD.
CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI) # ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE REPORTED PCA MODULE NOT RECORDING DEMAND DOSES DURING A MORPHINE INFUSION WAS NOT OBSERVED IN THE DEVICE LOGS OR REPLICATED DURING FUNCTIONAL TESTING. ¿ A REVIEW OF THE LOGS WAS PERFORMED FOR THE INCIDENT PCA DOSE ONLY INFUSION OF HYDROMORPHONE (DRUG ID 431) AND IS SUMMARIZED BELOW. ¿ FIRST PROGRAMMED INFUSION WITH A MONO 35ML SYRINGE, WITH A VOLUME OF 29.8ML. ¿ ON (B)(6) 2023 AT 11:46 AM, THE USER CLEARED THE PCA PATIENT HISTORY. ONE MINUTE LATER THE SUSPECT PCA MODULE WAS PROGRAMMED TO DELIVER PCA DOSE ONLY OF 2.3MG. PVI WAS RECORDED AS 1140.2ML. ¿ FROM (B)(6) 2023 AT 11:46 AM TO (B)(6) 2023 AT 7:10 AM, THIRTEEN (13) DOSE REQUEST WERE PERFORMED AND SUCCESSFULLY DELIVERED FOR A VOLUME INFUSED OF 29.89ML. PRIMARY VOLUME INFUSED WAS RECORDED AS 1170.1ML. ¿ AT 7:10 AM, THE PCA MODULE ALARMED FOR SYRINGE EMPTY. ¿ AT 7:16 AM, THE PCA MODULE WAS CHANNELED OFF. ¿ SECOND PROGRAMMED INFUSION WITH A MONO 35ML SYRINGE, WITH A VOLUME OF 29.8ML. ¿ AT 7:20 AM, THE SUSPECT PCA MODULE¿S PREVIOUS PCA DOSE ONLY INFUSION OF 2.3MG WAS RESTORED/STARTED. PVI WAS RECORDED AS 1170.1ML. ¿ FROM 8:42 AM TO 11:36 AM, ELEVEN (11) PCA DOSES INCLUDING A PARTIAL DOSE OF 0.8MG WERE REQUESTED AND SUCCESSFULLY DELIVERED. TWO (2) ADDITIONAL MANUAL PCA DOSES (EACH OF 3MG) WERE PROGRAMMED AND DELIVERED, THE TOTAL VOLUME INFUSED OF 29.8ML. ¿ AT 11:09 AM, THE PATIENT HISTORY WAS CLEARED BY THE USER. ¿ AT 11:36 AM, THE PCA MODULE ALARMED FOR SYRINGE EMPTY. PRIMARY VOLUME INFUSED WAS RECORDED AS 1199.9ML ¿ AT 11:44 AM, THE PCA MODULE WAS CHANNELED OFF. ¿ A REVIEW OF THE DEVICE LOGS DID NOT OBSERVE ANY PCA DOSE REQUESTS THAT WERE MADE AND NOT FULFILLED AND ALL PCA DOSE REQUESTS WERE MADE AFTER THE 10-MINUTE LOCKOUT PERIOD WITH THE EXEMPTION OF THE TWO ADDITIONAL MANUAL PCA DOSES. ¿ A REVIEW OF THE DEVICE ERROR LOGS OBSERVED NO ERRORS OR MALFUNCTIONS RELATED TO THE REPORTED ISSUE. ¿ THE BD ALARIS USER MANUAL VERSION 12.1.2, CONTAINS INFORMATION RELATED TO VIEWING PATIENT HISTORY, CLEARING PATIENT HISTORY, VIEWING AND CLEARING VOLUME INFUSED: ¿ ONCE PATIENT HISTORY IS CLEARED, THE LAST 24 HOURS OF PATIENT HISTORY DATA CAN BE RETRIEVED AND VIEWED. TO RETRIEVE LAST 24 HOURS, PRESS 24 H TOTALS SOFT KEY FROM PATIENT HISTORY SCREEN. ¿ 24 H TOTALS SOFT KEY APPEARS ONLY IF SHIFT TOTAL IS CLEARED, AND ADDITIONAL PATIENT HISTORY INFORMATION EXISTS (UP TO PREVIOUS 24 HOURS). ¿ NOTE: 24-H TOTALS DISPLAYS A ROLLING 24-HOUR HISTORY REGARDLESS OF HOW MANY TIMES THE PATIENT HISTORY HAS BEEN CLEARED. ¿ THE ZOOM SOFT KEY IS AVAILABLE TO VIEW DESIRED TIME HISTORY THE TIME PERIODS OPTIONS ARE 1,2,3,4,8,12, OR 24 HOUR VIEWS. THE LARGER THE TIME PERIOD VIEW, THE LESS CHANCE OF MISSED DATA. ¿ ONCE PCA HISTORY IS CLEARED IT IS NOT RETRIABLE AND WILL DISPLAY THE ROLLING 24HOUR TOTAL AFTER IT HAS BEEN CLEARED. O TO VIEW VOLUME INFUSED, PRESS THE VOLUME INFUSED SOFT KEY FROM MAIN DISPLAY. O TOTAL VOLUME INFUSED, AND TIME AND DATE VOLUME INFUSED WAS LAST CLEARED, ARE DISPLAYED FOR EACH CHANNEL. O NOTE: CLEARING VOLUME INFUSED ON A PCA MODULE DOES NOT CLEAR PATIENT HISTORY. ¿ BD¿S ONLINE KNOWLEDGE CENTER CONTAINS USEFUL RESOURCES RELATED TO PCA FUNCTIONS. SEE THE FOLLOWING LINK BELOW. O HTTPS://WWW.BD.COM/EN-US/RESOURCE-AND-EDUCATION/DOCUMENTATION-LANDING-PAGE?HEROSEARCHVALUE=PCA&LASTUPDATE=ALL-DATES&VID=4895924637001 ¿ PER THE BD ALARIS USER MANUAL VERSION 12.1.2, PROPER OPERATION OF THE BD ALARIS¿ SYSTEM REQUIRES THAT YOU ARE FAMILIAR WITH RELATED FEATURES, SETUP, PROGRAMMING, IV SETS, AND ACCESSORIES. READ ALL INSTRUCTIONS, INCLUDING THOSE FOR ALL ATTACHED MODULE(S) BEFORE USING THE BD ALARIS¿ SYSTEM. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED PCA MODULE NOT RECORDING DEMAND DOSES DURING THE INFUSION OF MORPHINE IS ATTRIBUTED TO A USE ERROR. LOG REVIEW DID NOT OBSERVE THE USER ATTEMPTING TO RETRIEVE THE AVAILABLE 24-HOUR PATIENT HISTORY AS OUTLINED IN THE BD ALARIS USER MANUAL VERSION 12.1.2. PROPER OPERATION OF THE BD ALARIS SYSTEM REQUIRES FAMILIARITY WITH RELATED FEATURES, SETUP, AND PROGRAMMING. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A0401, A040502, A0404, G02017, C07, C0601, C17, D15, D01, D07 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.
OMIT : B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION 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.
IT WAS REPORTED THAT A PCA INFUSION OF MORPHINE (30MG/30ML) IN A CARDINAL HEALTH MONOJECT 35ML SYRINGE WAS PROGRAMMED WITH A PCA DEMAND DOSE OF 2.3MG WITH A 10-MINUTE LOCKOUT. IT WAS REPORTED THE MODULE ALLEGEDLY DID NOT RECORD THE DEMAND DOSES GIVEN, NUMBER OF ATTEMPTS AND TOTAL DRUG ADMINISTERED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. CUSTOMER IS REQUESTING LOG REVIEW REGARDING INFORMATION ON THE NUMBER OF DEMAND DOSES GIVEN, THE NUMBER OF ATTEMPTS, AND TOTAL DRUG DELIVERED FROM 11/20 ¿ 11/21. IT WAS REPORTED THAT THE 30 ML SYRINGE INFUSED FROM 11/20, 2345 ¿ 11/21, 0724. DURING THIS TIME THE DEMAND DOSE INFORMATION ALLEGEDLY DID NOT DISPLAY. ANOTHER SYRINGE WAS ADMINISTERED FROM 0724 ¿ 1155 AND AGAIN THE NURSE NOTED THE INFORMATION WAS NOT DISPLAYING SO UNABLE TO CHART PCA USAGE.
IT WAS REPORTED THAT A PCA INFUSION OF MORPHINE (30MG/30ML) IN A CARDINAL HEALTH MONOJECT 35ML SYRINGE WAS PROGRAMMED WITH A PCA DEMAND DOSE OF 2.3MG WITH A 10-MINUTE LOCKOUT. IT WAS REPORTED THE MODULE ALLEGEDLY DID NOT RECORD THE DEMAND DOSES GIVEN, NUMBER OF ATTEMPTS AND TOTAL DRUG ADMINISTERED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. CUSTOMER IS REQUESTING LOG REVIEW REGARDING INFORMATION ON THE NUMBER OF DEMAND DOSES GIVEN, THE NUMBER OF ATTEMPTS, AND TOTAL DRUG DELIVERED FROM (B)(6). IT WAS REPORTED THAT THE 30 ML SYRINGE INFUSED FROM (B)(6), 2345 ¿ (B)(6), 0724. DURING THIS TIME THE DEMAND DOSE INFORMATION ALLEGEDLY DID NOT DISPLAY. ANOTHER SYRINGE WAS ADMINISTERED FROM 0724 ¿ 1155 AND AGAIN THE NURSE NOTED THE INFORMATION WAS NOT DISPLAYING SO UNABLE TO CHART PCA USAGE.
IT WAS REPORTED THAT A PCA INFUSION OF MORPHINE (30MG/30ML) IN A CARDINAL HEALTH MONOJECT 35ML SYRINGE WAS PROGRAMMED WITH A PCA DEMAND DOSE OF 2.3MG WITH A 10-MINUTE LOCKOUT. IT WAS REPORTED THE MODULE ALLEGEDLY DID NOT RECORD THE DEMAND DOSES GIVEN, NUMBER OF ATTEMPTS AND TOTAL DRUG ADMINISTERED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. CUSTOMER IS REQUESTING LOG REVIEW REGARDING INFORMATION ON THE NUMBER OF DEMAND DOSES GIVEN, THE NUMBER OF ATTEMPTS, AND TOTAL DRUG DELIVERED FROM 11/20 ¿ 11/21. IT WAS REPORTED THAT THE 30 ML SYRINGE INFUSED FROM 11/20, 2345 ¿ 11/21, 0724. DURING THIS TIME THE DEMAND DOSE INFORMATION ALLEGEDLY DID NOT DISPLAY. ANOTHER SYRINGE WAS ADMINISTERED FROM 0724 ¿ 1155 AND AGAIN THE NURSE NOTED THE INFORMATION WAS NOT DISPLAYING SO UNABLE TO CHART PCA USAGE.
IT WAS REPORTED THAT A PCA INFUSION OF MORPHINE (30MG/30ML) IN A CARDINAL HEALTH MONOJECT 35ML SYRINGE WAS PROGRAMMED WITH A PCA DEMAND DOSE OF 2.3MG WITH A 10-MINUTE LOCKOUT. IT WAS REPORTED THE MODULE ALLEGEDLY DID NOT RECORD THE DEMAND DOSES GIVEN, NUMBER OF ATTEMPTS AND TOTAL DRUG ADMINISTERED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. CUSTOMER IS REQUESTING LOG REVIEW REGARDING INFORMATION ON THE NUMBER OF DEMAND DOSES GIVEN, THE NUMBER OF ATTEMPTS, AND TOTAL DRUG DELIVERED FROM 11/20 ¿ 11/21. IT WAS REPORTED THAT THE 30 ML SYRINGE INFUSED FROM 11/20, 2345 ¿ 11/21, 0724. DURING THIS TIME THE DEMAND DOSE INFORMATION ALLEGEDLY DID NOT DISPLAY. ANOTHER SYRINGE WAS ADMINISTERED FROM 0724 ¿ 1155 AND AGAIN THE NURSE NOTED THE INFORMATION WAS NOT DISPLAYING SO UNABLE TO CHART PCA USAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111496 | ALARIS SYSTEM | PUMP, INFUSION | MEA | CAREFUSION SD | 8120 | 10885403812033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |