ALARIS SYSTEM
Report
- Report Number
- 2016493-2026-06555
- Event Type
- Malfunction
- Date Received
- February 16, 2026
- Date of Event
- January 29, 2026
- Report Date
- March 18, 2026
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OMIT: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION: OTHER RELEVANT HISTORY, UNIQUE IDENTIFIER (UDI) #, MEDICAL DEVICE SERIAL #, DEVICE MANUFACTURE DATE, IMDRF ANNEX A, B, C, D, G CODES AND MANUFACTURER NARRATIVE. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 FAILURE TO ALARM FOR AIR IN LINE COULD NOT BE CONFIRMED. LOG ANALYSIS SHOWED THAT THE DEVICE WAS ACTIVELY ALARMING FOR AIR IN LINE ON THE DATE OF THE EVENT. LABORATORY TESTING COULD NOT BE PERFORMED BECAUSE NEITHER THE DEVICE NOR THE ADMINISTRATION SET WAS PROVIDED BY THE FACILITY. THE FACILITY REPORTED THE EVENT OCCURRING ON (B)(6) 2026; TIME OF EVENT WAS REPORTED TO BE 04:15 AM. ERROR AND EVENT LOGS FROM PCU AND PUMP MODULE WERE PROVIDED BY FACILITY; HOWEVER, THE SUSPECT AND CONCOMITANT DEVICES WERE NOT RETURNED FOR INVESTIGATION. THE REVIEW OF THE PUMP MODULE AND PCU LOGS SHOWED NO ERRORS OR MALFUNCTIONS RELATED TO THE REPORTED INCIDENT DURING (B)(6) 2026 TO (B)(6) 2026. ON (B)(6) 2026 AT 10:32 PM, THE PUMP MODULE WAS PROGRAMMED TO INFUSE A PRIMARY INFUSION OF PITOCIN DRUG, RATE OF 75 ML/H AND VOLUME TO BE INFUSED (VTBI) = 450 ML. AT 10:34 PM, THE PUMP MODULE WAS PROGRAMMED FOR A SECONDARY INFUSION WITH CEFAZOLIN (ANCEF) DRUG, DRUG AMOUNT = 2 GRAMS; VOLUME = 100 ML, CONCENTRATION = 0.02 GRAMS/ML AND RATE 200 ML/H; PRIMARY VOLUME INFUSED (PVI) = 2.242 ML AND SECONDARY VOLUME INFUSED (SVI) = 0 ML. THE INFUSION LASTED THIRTY (30) MINUTES, AND 100 ML WAS RECORDED TO HAVE BEEN INFUSED. ON (B)(6) 2026 AT 4:22 AM THE PUMP MODULE ALARMED FOR ACCUMULATED AIR IN LINE, FIVE (5) MINUTES LATER THE USER PRESSED KEY CHANNEL OFF AND THE PCU WAS POWERED OFF; PVI = 399.042 ML AND SVI = 100.022 ML. AT 4:41 AM, THE SYSTEM WAS POWERED ON WITH PVI = 399.042 ML AND SVI = 100.022 ML. AT 4:47 AM, THE PUMP MODULE RESTORED A PREVIOUS INFUSION WITH PITOCIN DRUG, RATE OF 75 ML/H AND VTBI = 50.985 ML; PVI = 399.042 ML AND SVI = 100.022 ML. THE INFUSION LASTED TWO (2) MINUTES AND 1.721 ML INFUSED. AT 4:50 AM THE PUMP MODULE ALARMED FOR AIR IN LINE, AND A MINUTE LATER THE USER PRESSES KEY CHANNEL OFF POWERING OFF THE PCU; PVI = 400.763 ML AND SVI = 100.022 ML. THE ALARIS SYSTEM USER MANUAL V12.3 SAYS ON CHAPTER 2-BD ALARIS PUMP MODULE MODEL 8100 AND BO ALARIS SYRINGE MODULE MODEL 8110 ON SUMMARY OF WARNINGS AND CAUTIONS THE NEXT STATEMENTS TO PREVENT AIR IN LINE ALARMS. THESE INCLUDE ENTERING A VTBI THAT IS LESS THAN OR EQUAL TO THE ACTUAL CONTAINER VOLUME, AS WELL AS ENSURING PROPER VENTING WHEN USING CONTAINERS SUCH AS GLASS BOTTLES AND BURETTES. AIR REACHING THE PATIENT COULD HAVE SERIOUS CONSEQUENCES, SUCH AS DECREASED OXYGENATION, SEIZURES, ARRHYTHMIA, STROKE, CARDIAC AND/OR RESPIRATORY ARREST. MINIMIZING AIR IN THE LINE IS PARTICULARLY IMPORTANT FOR LOW, VERY LOW, AND EXTREMELY LOW BIRTH WEIGHT NEONATES. THE ACCUMULATED AIR-IN-LINE OPTION IS SET TO DISABLE, THE SYSTEM ALARM ONLY WHEN IT DETECTS AN AIR BOLUS LARGER THAN THE BOLUS SIZE SET AS THE AIR-IN-LINE DETECTION THRESHOLD EITHER 50, 75, OR 250MICROL. (IN ANESTHESIA MODE ONLY, THE THRESHOLD VALUE CAN BE SET TO 500MICROL). WHEN ENABLE IS SELECTED, NOT ONLY DOES THE AIR-IN-LINE SYSTEM DETECT AND RESPOND TO A BOLUS SIZE GREATER THAN THE SELECTED AIR-IN-LINE THRESHOLD OF 50, 75, 250, OR 500MICROL, IT ALSO DETECTS AND RESPONDS TO MULTIPLE SMALL BOLUSES OF A PRE-DETERMINED NUMBER, DEPENDING ON THE BOLUS SIZE SELECTED AS THE AIR-IN-LINE DETECTION THRESHOLD. THE AIR-IN-LINE DETECTION THRESHOLD SPECIFIES THE AMOUNT OF AIR THAT CAN PASS THROUGH THE DETECTOR IN A SINGLE BOLUS BEFORE AN ALARM SOUNDS. IN NORMAL USE, THE THRESHOLD CAN BE SET AT 50, 75, OR 250MICROL. THE DEFAULT SETTING IS 75MICROL. (IN ANESTHESIA MODE ONLY, THE THRESHOLD VALUE CAN BE SET TO 500MICROL). THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED FAILURE TO ALARM FOR AIR IN LINE COULD NOT BE CONFIRMED. LOG ANALYSIS SHOWED THAT THE DEVICE WAS ACTIVELY ALARMING FOR AIR IN LINE ON THE DATE OF THE EVENT. THE INSPECTION PROCESS AND LABORATORY TESTING OF THE DEVICE AND ADMINISTRATION SET COULD NOT BE PERFORMED BECAUSE THEY WERE NOT RETURNED FOR INVESTIGATION. 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.
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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.
IT WAS REPORTED THAT PUMP MODULE CONTINUED TO INFUSE EVEN WITH VISIBLE AIR BUBBLES IN THE AIR DETECTION CHAMBER. THE FLUIDS HANGING AND TO BE INFUSED WERE PITOCIN 450ML AND ANCEF 100ML. THERE WAS PATIENT INVOLVEMENT, HOWEVER IT WAS NOTED THAT THE PATIENT WAS PROVIDED O2 AND WENT HOME. THE CUSTOMER ALSO PROVIDED THE FOLLOWING INFORMATION FROM THE NURSE: THE GRAVITY HUNG BOLUS COMPLETED AT 2230 AND THEY PLACED THE 500ML BAG OF PITOCIN (450 ENTERED AT THE VOLUME TO BE INFUSED) AND ANCEF BAG THAT WAS BROUGHT OVER WITH THE PATIENT "((B)(6))" AT 2230. THE ANCEF WOULD HAVE COMPLETED IN 1 HOUR AND THEN THE PITOCIN WOULD HAVE BEGUN TO INFUSE. THE PUMP MODULE ALARMED AT 0315 FOR "LOW BATTERY" AND ACCORDING TO THE NUSE THERE WAS AN HOUR OF FLUID LEFT TO INFUSE. WHEN THEY HEARD THE PUMP MODULE BEEPING, THE PATIENT CALLED LETTING THEM KNOW THAT IT WAS BEEPING AND THEY FOUND THE IV TUBING. THE CUSTOMER LATER HAD THE FOLLOWING QUESTION: "I WANTED TO FOLLOW UP AND SEE IF YOU ALL HAVE FOUND ANYTHING QUESTIONABLE OR OUT OF THE NORM ON WHY THEY THINK IT KEPT ON INFUSING OR POSSIBLY A KVO AND BUBBLES WERE ALLOWED PAST."
IT WAS REPORTED THAT PUMP MODULE CONTINUED TO INFUSE EVEN WITH VISIBLE AIR BUBBLES IN THE AIR DETECTION CHAMBER. THE FLUIDS HANGING AND TO BE INFUSED WERE PITOCIN 450ML AND ANCEF 100ML. THERE WAS PATIENT INVOLVEMENT, HOWEVER IT WAS NOTED THAT THE PATIENT WAS PROVIDED O2 AND WENT HOME. THE CUSTOMER ALSO PROVIDED THE FOLLOWING INFORMATION FROM THE NURSE: THE GRAVITY HUNG BOLUS COMPLETED AT 2230 AND THEY PLACED THE 500ML BAG OF PITOCIN (450 ENTERED AT THE VOLUME TO BE INFUSED) AND ANCEF BAG THAT WAS BROUGHT OVER WITH THE PATIENT "(100)" AT 2230. THE ANCEF WOULD HAVE COMPLETED IN 1 HOUR AND THEN THE PITOCIN WOULD HAVE BEGUN TO INFUSE. THE PUMP MODULE ALARMED AT 0315 FOR "LOW BATTERY" AND ACCORDING TO THE NUSE THERE WAS AN HOUR OF FLUID LEFT TO INFUSE. WHEN THEY HEARD THE PUMP MODULE BEEPING, THE PATIENT CALLED LETTING THEM KNOW THAT IT WAS BEEPING AND THEY FOUND THE IV TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455562 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | 8015| 8015 |