ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-64173
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Date of Event
- February 7, 2025
- Report Date
- November 27, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403516047
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
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 : OTHER OCCUPATION, B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS 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. 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. INVESTIGATION SUMMARY : THE REPORTED COMPLAINT OF UNKNOWN SYRINGE INSTALLED COULD NOT BE CONFIRMED. SYRINGE TESTING FOUR SYRINGES OF DIFFERENT SIZES (50 ML, 30 ML, 12 ML, AND 6 ML) WERE TESTED. THE BD PLASTIPAK 50 ML, BD PLASTIPAK 30 ML, AND MONOJECT 12 ML WERE CORRECTLY RECOGNIZED, MEETING THE ALARIS SYSTEM REQUIREMENTS WITH AN ACCURACY OF ±2% OF FULL-SCALE PLUNGER TRAVEL. THE MONOJECT 6 ML SYRINGE WAS MISIDENTIFIED AS THE BD PLASTIPAK 5 ML, REVEALING THAT THE PCU LIBRARY LACKED UPDATES FOR THE LATEST BD-AUTHORIZED SYRINGES. PREVENTIVE MAINTENANCE (PM) WAS CONDUCTED USING ASM V12.5. ALL REQUIRED PM TESTS WERE SUCCESSFULLY PASSED. NO DAMAGE WAS SHOWN ON EXTERNAL INSPECTION, ALL PARTS WERE MANUFACTURED BY BD. NO CONDITION WAS IDENTIFIED DURING THE INTERNAL OR EXTERNAL INSPECTION THAT IS LINKED TO THE REPORTED EVENT. THE REVIEW OF THE SYRINGE MODULE ERROR LOGS FOUND NO ERRORS OR MALFUNCTIONS RELATED TO THE REPORTED EVENT OR RELATED TO THE COMPLAINT DATE. USE ONLY THE SYRINGE SIZE AND TYPE SPECIFIED ON THE MAIN DISPLAY. THE FULL LIST OF PERMITTED SYRINGE MODELS IS DEPENDENT ON THE SYRINGE MODULE¿S SOFTWARE VERSION. DO NOT USE INCOMPATIBLE SYRINGE SIZES AND MODELS WITH THE SYRINGE MODULE. USE OF INCOMPATIBLE SYRINGES CAN IMPACT PUMP OPERATION RESULTING IN INACCURATE FLUID DELIVERY, DELAYED GENERATION OF OCCLUSION ALARMS, AND OTHER POTENTIAL PROBLEMS (REFER TO THE BD ALARIS¿ SYSTEM WITH GUARDRAILS¿ SUITE MX USER MANUAL). ENSURE THAT THE DISPLAYED SYRINGE MANUFACTURER AND SYRINGE SIZE MATCH THE INSTALLED SYRINGE. MISMATCHES CAN IMPACT FLOW RATE ACCURACY. THE DEVICE WAS REPORTED TO HAVE BEEN IN USE NOT AS INTENDED FOR TREATMENT PURPOSES AS DESIGNED BY BD PER 21CFR 820.198(D)(2). NOTES TO SERVICE DEVICE WAS OPENED FOR INVESTIGATION. PLEASE RE-TORQUE ALL SCREWS. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT COVER THE COSTS ASSOCIATED WITH ANY INCIDENTAL FINDINGS OR PHYSICALLY ABUSED COMPONENTS. ROOT CAUSE: THE ROOT CAUSE OF UNKNOWN SYRINGE INSTALLED COULD NOT BE IDENTIFIED. DATA SET WERE NOT PROVIDED BY THE FACILITY. A PROBABLE CAUSE OF THE FAILURE COULD BE THE SYRINGE MODULE¿S SOFTWARE VERSION, AND NOT ENABLING THE SYRINGES USED IN THE GUARDRAILS¿ EDITOR SOFTWARE.
OMIT: A20 - INSTALLATION-RELATED PROBLEM (2965), G0200802 - SOFTWARE INTERFACE. ADDITIONAL INFORMATION: IMDRF ANNEX A, G 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 REPORTED COMPLAINT OF UNKNOWN SYRINGE INSTALLED COULD NOT BE CONFIRMED. SYRINGE TESTING FOUR SYRINGES OF DIFFERENT SIZES (50 ML, 30 ML, 12 ML, AND 6 ML) WERE TESTED. THE BD PLASTIPAK 50 ML, BD PLASTIPAK 30 ML, AND MONOJECT 12 ML WERE CORRECTLY RECOGNIZED, MEETING THE ALARIS SYSTEM REQUIREMENTS WITH AN ACCURACY OF ±2% OF FULL-SCALE PLUNGER TRAVEL. THE MONOJECT 6 ML SYRINGE WAS MISIDENTIFIED AS THE BD PLASTIPAK 5 ML, REVEALING THAT THE PCU LIBRARY LACKED UPDATES FOR THE LATEST BD-AUTHORIZED SYRINGES. PREVENTIVE MAINTENANCE (PM) WAS CONDUCTED USING ASM V12.5. ALL REQUIRED PM TESTS WERE SUCCESSFULLY PASSED. NO DAMAGE WAS SHOWN ON EXTERNAL INSPECTION, ALL PARTS WERE MANUFACTURED BY BD. NO CONDITION WAS IDENTIFIED DURING THE INTERNAL OR EXTERNAL INSPECTION THAT IS LINKED TO THE REPORTED EVENT. THE REVIEW OF THE SYRINGE MODULE ERROR LOGS FOUND NO ERRORS OR MALFUNCTIONS RELATED TO THE REPORTED EVENT OR RELATED TO THE COMPLAINT DATE. USE ONLY THE SYRINGE SIZE AND TYPE SPECIFIED ON THE MAIN DISPLAY. THE FULL LIST OF PERMITTED SYRINGE MODELS IS DEPENDENT ON THE SYRINGE MODULE¿S SOFTWARE VERSION. DO NOT USE INCOMPATIBLE SYRINGE SIZES AND MODELS WITH THE SYRINGE MODULE. USE OF INCOMPATIBLE SYRINGES CAN IMPACT PUMP OPERATION RESULTING IN INACCURATE FLUID DELIVERY, DELAYED GENERATION OF OCCLUSION ALARMS, AND OTHER POTENTIAL PROBLEMS (REFER TO THE BD ALARIS¿ SYSTEM WITH GUARDRAILS¿ SUITE MX USER MANUAL). ENSURE THAT THE DISPLAYED SYRINGE MANUFACTURER AND SYRINGE SIZE MATCH THE INSTALLED SYRINGE. MISMATCHES CAN IMPACT FLOW RATE ACCURACY. THE DEVICE WAS REPORTED TO HAVE BEEN IN USE NOT AS INTENDED FOR TREATMENT PURPOSES AS DESIGNED BY BD PER 21CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF UNKNOWN SYRINGE INSTALLED COULD NOT BE IDENTIFIED. DATA SET WERE NOT PROVIDED BY THE FACILITY. A PROBABLE CAUSE OF THE FAILURE COULD BE THE SYRINGE MODULE¿S SOFTWARE VERSION, AND NOT ENABLING THE SYRINGES USED IN THE GUARDRAILS¿ EDITOR SOFTWARE. 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 DURING CLASSROOM STAFF EDUCATION BEING CONDUCTED BY BD REPRESENTATIVE, "UNKNOWN SYRINGE INSTALLED" MESSAGE APPEARED WHEN A BD 30ML SYRINGE (REF:(B)(4)./LOT:4122461) WAS INSTALLED ON SYRINGE MODULE SERIAL NUMBER (B)(6) . WHEN BD PLASTIPAK 10ML SYRINGE WAS INSTALLED INTO SYRINGE MODULE SERIAL NUMBER XXXX0107, IT WAS READ AS "MONOJECT 10ML" AND "TERUMO 10ML" SYRINGES. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT DURING CLASSROOM STAFF EDUCATION BEING CONDUCTED BY BD REPRESENTATIVE, "UNKNOWN SYRINGE INSTALLED" MESSAGE APPEARED WHEN A BD 30ML SYRINGE (REF: (B)(4) / LOT:4122461) WAS INSTALLED ON SYRINGE MODULE SERIAL NUMBER (B)(6). WHEN BD PLASTIPAK 10ML SYRINGE WAS INSTALLED INTO SYRINGE MODULE SERIAL NUMBER (B)(6), IT WAS READ AS "MONOJECT 10ML" AND "TERUMO 10ML" SYRINGES. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT DURING CLASSROOM STAFF EDUCATION BEING CONDUCTED BY BD REPRESENTATIVE, "UNKNOWN SYRINGE INSTALLED" MESSAGE APPEARED WHEN A BD 30ML SYRINGE (REF: (B)(4)/LOT: 4122461) WAS INSTALLED ON SYRINGE MODULE SERIAL NUMBER: (B)(6). WHEN BD PLASTIPAK 10ML SYRINGE WAS INSTALLED INTO SYRINGE MODULE SERIAL NUMBER: (B)(6), IT WAS READ AS "MONOJECT 10ML" AND "TERUMO 10ML" SYRINGES. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2275846 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403516047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015 |