ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-135481
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- October 30, 2025
- Report Date
- December 25, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403516047
- PMA / PMN Number
- K211218
- Removal / Correction Number
- Z-0185-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.
CORRECTION: DESCRIBE EVENT OR PROBLEM. OMIT: CONCOMITANT MED PROD DATA, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION: IMDRF ANNEX A, G, B, C AND D CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # 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 UNDER INFUSION EVENT WAS NOT ABLE TO BE CONFIRMED SINCE NO DEVICES WERE RETURNED; HOWEVER, THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO A USER ERROR. EXTERNAL AND INTERNAL INSPECTION WERE NOT PERFORMED AS NO DEVICES OR PRODUCT WERE RETURNED FOR INVESTIGATION. TESTING WAS NOT PERFORMED AS NO DEVICES OR PRODUCTS WERE RETURNED FOR INVESTIGATION. HOWEVER, THE FACILITY PROVIDED A PICTURE OF THEIR CURRENT DATASET WHICH CONTAINS THE COMPATIBLES SYRINGES. AS WELL A PICTURE OF AN OLD VERSION OF BD COMPATIBLE SYRINGES CHART WAS PROVIDED IN ORDER TO REPLACE THE BD PLASTIPAK 5 ML_ SYRINGE WITH A MONOJECT 6 ML_ SYRINGE CONTAINED IN THE OLD, APPROVED CHART. IT WAS OBSERVED THAT THE PROVIDED DATASET HAS BEEN UPDATED TO REFLECT THE MOST RECENT VERSION OF COMPATIBLE SYRINGES; THEREFORE, THE MONOJECT 6 ML SYRINGE IS NO LONGER LISTED AS COMPATIBLE IN EITHER THE UPDATED DATASET OR THE LATEST COMPATIBILITY CHART. LIKEWISE, THE REPORTED SYRINGE (BD ECLIPSE 1 ML) DOES NOT APPEAR IN THE LIST OF COMPATIBLE SYRINGES. THE ALARIS SYSTEM WITH GUARDRAILS USER MANUAL V12.3.1 STATES THAT TO DECREASE POTENTIAL STARTUP DELAYS, DELIVERY INACCURACIES, AND DELAYED GENERATION OF OCCLUSION ALARMS EACH TIME A NEW SYRINGE IS LOADED: USE THE SMALLEST SYRINGE SIZE POSSIBLE TO DELIVER THE FLUID OR MEDICATION. USE THE PRIME SET WITH SYRINGE FEATURE IN THE CHANNEL OPTIONS MENU, WHEN STARTING AN INFUSION OR CHANGING THE SYRINGE AND TUBING, ESPECIALLY WHEN INFUSING AT LOW FLOW RATES OR DELIVERING LOADING BOLUSES, TO DECREASE PUMP MECHANICAL SLACK. FAILURE TO DO SO CAN DELAY THE INFUSION DELIVERY STARTUP TIME AND LEAD TO DELIVERY INACCURACIES. USE COMPATIBLE COMPONENTS THAT HAVE THE SMALLEST INTERNAL VOLUME OR DEAD SPACE TO MINIMIZE THE RESIDUAL VOLUMES BETWEEN THE SYRINGE AND THE PATIENT. THICK LABELING OR ADDING A COMPONENT TO THE SYRINGE THAT IS LARGER THAN THE DIAMETER OF THE SYRINGE MAY PREVENT THE DEVICE FROM CORRECTLY RECOGNIZING THE INSTALLED SYRINGE. SELECTING AN INCORRECT SYRINGE MAY CAUSE AN UNDERINFUSION OR OVER INFUSION TO THE PATIENT. THE MANUAL ALSO STATES THAT 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) AND ASSOCIATED DISPOSABLES BEFORE USING THE BD ALARIS¿ SYSTEM. ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED UNDER INFUSION EVENT COULD NOT BE DETERMINED AS NO DEVICES WERE RETURNED FOR INVESTIGATION; HOWEVER, THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO A USER ERROR. THE PROVIDED INFORMATION INDICATES THAT THE BD ECLIPSE 1 ML SYRINGE IS NOT INCLUDED IN THE APPROVED COMPATIBLE SYRINGE LIST. 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 THE SYRINGE MODULE WAS ADMINISTERING 1 ML OF MEDICATION VIA IO. WHEN VOLUME TO BE INFUSED (VTBI) REACHED 0, THERE WAS VISUALLY 0.4 ML REMAINING IN SYRINGE. NURSES MANUALLY REPROGRAMED TO DELIVER ENTIRE DOSE. THEY HAD DRAWN UP THE DOSE THEMSELVES AND STATED THERE WAS DEFINITELY 1 ML IN SYRINGE. NURSE STATED THAT INFORMATION SENT TO THE PUMP WAS ACCURATE. NOTED THAT THE STOCKED 1ML BD SYRINGE IS NOT ON THE COMPATIBLE LIST. SYRINGE IS BD ECLIPSE 1 ML 30G X1/2", REF (B)(6). THE PROJECT TEAM IS CONCERNED THAT THERE IS ONLY ONE APPROVED BD SYRINGE FOR 1 ML DOSE. THERE WAS NO PATIENT HARM.
IT WAS REPORTED THAT THE SYRINGE MODULE WAS ADMINISTERING 1 ML OF HYDROCORTISONE VIA IO. THE PROGRAMMED RATE WAS 3ML/HR WITH THE VOLUME TO BE INFUSED OF 1 ML. WHEN VOLUME TO BE INFUSED (VTBI) REACHED 0, THERE WAS VISUALLY 0.4 ML REMAINING IN SYRINGE. NURSES MANUALLY REPROGRAMED TO DELIVER ENTIRE DOSE. THEY HAD DRAWN UP THE DOSE THEMSELVES AND STATED THERE WAS DEFINITELY 1 ML IN SYRINGE. NURSE STATED THAT INFORMATION SENT TO THE PUMP WAS ACCURATE. NOTED THAT THE STOCKED 1ML BD SYRINGE IS NOT ON THE COMPATIBLE LIST. SYRINGE IS BD ECLIPSE 1 ML 30G X1/2", REF 305778. THE PROJECT TEAM IS CONCERNED THAT THERE IS ONLY ONE APPROVED BD SYRINGE FOR 1 ML DOSE. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2882511 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403516047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |