ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-44307
- Event Type
- Malfunction
- Date Received
- December 11, 2024
- Date of Event
- November 14, 2024
- Report Date
- February 6, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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.
OMIT: B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER? , IMDRF ANNEX A,G,B,C,D CODES AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE REPORT OF THE DEVICE NOT INFUSING IMMUNE GLOBULIN WAS NOT CONFIRMED THROUGH A REVIEW OF THE DEVICE LOGS OR LABORATORY TESTING. ¿ LABORATORY TEST RESULTS PERFORMED ON THE SUSPECT PUMP MODULE CONFIRMED THE DEVICE TO BE WITHIN SPECIFICATION AND OPERATING AS INTENDED. THE DEVICE WAS FOUND TO BE DELIVERING FLUID AND DETECTING OCCLUSION WITHIN SPECIFICATION. ¿ A REVIEW OF THE SUSPECT PUMP MODULE ERROR LOG SHOWED NO ANOMALIES RELATED TO THE REPORTED COMPLAINT. ¿ A REVIEW OF THE PCU EVENT LOGS SHOWED THAT ON 14NOV2024 AT 11:10:34 AM THE PCU WAS POWERED ON. AT 11:12:13 AM THE SUSPECT PUMP MODULE WAS SELECTED FOR PROGRAMMING; IMMUNE GLOBULIN (DRUGID=236); RATE=59 ML/H; VOLUME TO BE INFUSED (VTBI)=190 ML; DRUG AMOUNT=40 G; PATIENT WEIGHT=98; DOSE=0.4082 G/KG. O AT 11:12:35 AM THE USER SELECTED THE UNIT AND REPROGRAMMED THE VTBI TO 185 ML. O AT 11:42:43 AM THE USER SELECTED THE UNIT AND REPROGRAMMED THE RATE TO 118 ML. PRIMARY VOLUME INFUSED (PVI)=29.664 ML. O AT 12:14:53 PM THE USER SELECTED THE UNIT AND REPROGRAMMED THE RATE TO 235 ML. PRIMARY VOLUME INFUSED (PVI)=92.885 ML. O AT 12:38:30 PM AFTER THE UNIT COMPLETED THE INFUSION, THE USER SELECTED THE UNIT AND REPROGRAMMED THE VTBI TO 150 ML. ONE (1) MINUTE LATER THE USER PAUSED THE UNIT. PVI=187.85 ML. O AT 12:42:22 PM THE USER CHANNELED OFF THE UNIT. ¿ THE TOTAL PRIMARY VOLUME INFUSED WAS RECORDED TO BE 185.85ML. ¿ IT IS NOT POSSIBLE TO DETERMINE WHAT THE ACTUAL VOLUME IS WITHIN AN IV CONTAINER AT THE START AND ENDING OF AN INFUSION FROM A REVIEW OF THE PCU EVENT LOG. IT IS ALSO NOT POSSIBLE TO DETERMINE WHAT THE FLUID IS THAT IS CONTAINED WITHIN THE IV CONTAINER. THIS IS NOT A FUNCTION OF THE PCU EVENT LOG; IT ONLY CAN REFLECT THE INPUTTED INFORMATION IT RECEIVES EITHER MANUALLY OR REMOTELY WITH RESPECT TO VOLUME TO BE DELIVERED AND FLUID SELECTED. ¿ INTERNAL AND EXTERNAL INSPECTION OF THE PUMP MODULE FOUND NO IRREGULARITIES. ¿ THE BD ALARIS SYSTEM USER MANUAL (V12.3), STATES WITHIN WARNINGS AND CAUTIONS ¿DO NOT TOUCH THE ADMINISTRATION SET WHILE CLOSING THE DOOR.¿ FAILURE TO FOLLOW THIS INSTRUCTION CAN RESULT IN INFUSION RATE INACCURACY. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE TO REPAIR CENTER: DEVICE OPENED FOR INVESTIGATION, PLEASE RE-TORQUE ALL SCREWS. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING FOR ANY INCIDENTAL ISSUES PRIOR TO RETURNING TO THE FACILITY. DCHU WILL NOT COVER THE COSTS ASSOCIATED WITH ANY INCIDENTAL FINDINGS OR PHYSICALLY ABUSED COMPONENTS. ROOT CAUSE: THE ROOT CAUSE OF THE REPORT OF THE DEVICE NOT INFUSING IMMUNE GLOBULIN WAS NOT IDENTIFIED DURING THE INVESTIGATION. REVIEW OF THE DEVICE LOGS AND LABORATORY TESTING PERFORMED DEMONSTRATED THE DEVICE WAS OPERATING AS INTENDED, AND NO FAULT WAS FOUND.
IT WAS REPORTED THAT IMMUNE GLOBULIN WAS PROGRAMMED TO INFUSE AT A RATE OF 52ML/HR WITH A TOTAL VOLUME TO BE INFUSED (VTBI) OF 185MLS; HOWEVER, NONE OF THE MEDICATION INFUSED OVER NINETY (90) MINUTES. THERE WAS NO ALARM INDICATING THE MEDICATION HAD NOT BEEN DELIVERED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.
IT WAS REPORTED THAT IMMUNE GLOBULIN WAS PROGRAMMED TO INFUSE AT A RATE OF 52ML/HR WITH A TOTAL VOLUME TO BE INFUSED (VTBI) OF 185MLS; HOWEVER, NONE OF THE MEDICATION INFUSED OVER NINETY (90) MINUTES. THERE WAS NO ALARM INDICATING THE MEDICATION HAD NOT BEEN DELIVERED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2597610 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015 |