ALARIS SYSTEM
Report
- Report Number
- 2016493-2026-14025
- Event Type
- Malfunction
- Date Received
- March 16, 2026
- Date of Event
- February 20, 2026
- Report Date
- April 6, 2026
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
OMIT: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION: REPORT SOURCE, IMDRF ANNEX A, B, C, D, 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 ISSUE, IN WHICH THE DEVICE AIR IN LINE SENSOR DID NOT FUNCTION AS EXPECTED, IS BEING ATTRIBUTED TO A USER ERROR. IT WAS IDENTIFIED DURING THE LOG REVIEW THAT TWO (2) AIR IN LINE ALARMS WERE SUPPRESSED AND WERE NOT ADDRESSED PROPERLY. THE FACILITY PROVIDED INFORMATION REGARDING THE REPORTED EVENT, FOUR PHOTOS OF A TUBING SET CONTAINING AIR BOLUSES WERE RETURNED, ALONG WITH THE FACILITY¿S TEST RESULTS. PER THE FACILITY¿S REPORT OF BIOMEDICAL TESTING AND INSPECTION, THE PUMP MODULE DID NOT PRESENT ANY PHYSICAL DAMAGE AND PASSED THEIR LABORATORY TESTS. EXTERNAL AND INTERNAL INSPECTION COULD NOT BE PERFORMED DUE TO THE DEVICES NOT BEING RETURNED FOR INVESTIGATION. THE DATE WAS REPORTED AS (B)(6) 2026. THE TIME WAS REPORTED BETWEEN 7:30 AM AND 9:06 AM. NO ERRORS OR DISCREPANCIES RELATED TO THE REPORTED EVENT WERE IDENTIFIED IN THE ERROR LOGS OF EITHER THE SUSPECT DEVICES. A REVIEW OF THE PROVIDED EVENT LOGS WAS PERFORMED, IT WAS OBSERVED THAT ON (B)(6) 2026, AT 6:14 AM, THE FIRST INFUSION WITH THE REPORTED DETAILS WAS PROGRAMMED USING A BASIC INFUSION PROGRAM (AS THE KEYSTROKES SUGGEST, THE PCU PROMPTED DIRECTLY TO ENTER RATE AND VOLUME TO BE INFUSED). PRIMARY VOLUME INFUSED (PVI)=96.553 ML; SECONDARY VOLUME INFUSED (SVI)=0. AT 6:56 AM THE USER SELECTED THE UNIT AND UPDATED THE VTBI TO 3.8 ML. PVI=99.231 ML. AT 7:37 AM THE UNIT ALARMED AIR IN LINE, THE USER SELECTED THE UNIT SHORTLY AFTER AND SELECTED THE CONFIRM SOFT KEY, CANCELLING THE ALARM. TWO (2) MINUTES LATER THE UNIT ALARMED AIR IN LINE A SECOND TIME, THE USER FOLLOWED AND SILENCED THE ALARM AND SIX MINUTES THE USER OPENED AND CLOSED THE DOOR IN A QUICK SUCCESSION (IT IS SUSPECTED THAT THE CLINICIAN DID NOT CLEAR THE TUBING OF AIR BOLUSES) AND CONFIRMED AND RESTARTED THE INFUSION. PVI=101.872 ML. AT 7:47 AM THE USER SELECTED THE UNIT AND UPDATED THE VTBI TO 3.8 ML AN ADDITIONAL TIME. AT 7:51 AM THE UNIT ALARMED PATIENT SIDE OCCLUSION, THE USER SELECTED THE UNIT SHORTLY AFTER AND SELECTED THE CONFIRM SOFT KEY, CANCELLING THE ALARM. AT 8:38 AM THE USER SELECTED THE UNIT AND UPDATED THE VTBI TO 3.8 ML A FINAL INSTANCE. AT 9:10 AM THE USER CHANNELED OFF THE UNIT. PVI=107.288 ML THE ALARIS SYSTEM USER MANUAL (V12.3), STATES THAT THE CLINICIAN MUST ENSURE THAT AIR IS EXPELLED FROM LINE PRIOR TO BEGINNING INFUSION AND INCORPORATE THE USE OF A 0.2 MICRON IN-LINE FILTER WHEN CLINICALLY APPROPRIATE FOR HIGH-RISK PATIENTS FOR EXAMPLE, LOW, VERY LOW, AND EXTREMELY LOW BIRTH WEIGHT NEONATES. AIR REACHING THE PATIENT COULD HAVE SERIOUS CONSEQUENCES, SUCH AS: DECREASED OXYGENATION, SEIZURES, ARRHYTHMIA, CARDIAC AND/OR RESPIRATORY ARREST. MINIMIZING AIR IN THE LINE IS PARTICULARLY IMPORTANT FOR LOW, VERY LOW, AND EXTREMELY LOW BIRTH WEIGHT NEONATES. TESTING COULD NOT BE PERFORMED DUE TO THE DEVICES NOT BEING RETURNED FOR INVESTIGATION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORT OF THE DEVICE NOT ALARMING FOR AIR IN LINE IS BEING ATTRIBUTED TO A USER ERROR, IT WAS IDENTIFIED DURING THE LOG REVIEW THAT TWO (2) AIR IN LINE ALARMS WERE SUPPRESSED WITH NO CLEAR SIGNS OF THE CLINICIAN REPLACING THE TUBING OR CLEANING THE AIR FROM THE LINE SINCE THE TIME FRAME OF THE ONLY INSTANCE OF THE SUSPECT PUMP MODULE ALARMING SAFETY CLAMP OPEN AND DOOR CLOSED AFTER THE LAST ALARM WAS OF JUST THREE SECONDS. 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.
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 THERE WAS AN INCIDENT IN THE NICU INVOLVING AN AIR-IN-LINE SENSOR THAT REPORTEDLY DID NOT FUNCTION AS EXPECTED. CLINICAL STAFF IDENTIFIED THAT AN AIR BUBBLE WAS ABOUT TO BE INFUSED. AT THE 07:30 SHIFT CHANGE, THE WRITER COMPLETED TRANSFER OF ACCOUNTABILITY WITH THE NIGHT NURSE FOR THE INFANT IN BED. THE BABY WAS IN AN INCUBATOR WITH D10W INFUSING VIA IV IN THE RIGHT HAND AT 3.8ML/HR. THE IV TUBING AND BURETROL WERE NOT DRY; ADDITIONAL FLUID WAS ADDED TO THE BURETROL IN THE PRESENCE OF THE NIGHT NURSE. THE IV SITE WAS DRY, INTACT, AND WITHOUT REDNESS OR SWELLING. AT 08:53, BLOOD WORK WAS DRAWN AND A BEDSIDE GLUCOSE CHECK SHOWED 4.4MMOL/L. AT 09:06, WHEN PREPARING TO SALINE-LOCK THE IV, THE WRITER OBSERVED APPROXIMATELY 15 CM OF AIR IN THE IV TUBING ABOUT TO REACH THE INFANT¿S HAND, ALONG WITH SEVERAL OTHER SMALLER AIR POCKETS (2¿3 CM EACH, ABOUT 5¿6 SECTIONS). THE IV WAS IMMEDIATELY SALINE-LOCKED. THROUGHOUT, THE INFANT REMAINED VITALLY STABLE WITH NORMAL BLOOD PRESSURE, NO RESPIRATORY DISTRESS, AND GOOD COLOR AND TONE. THE HOSPITAL BIOMED HAS COMPLETED INITIAL TESTING OF THE DEVICE; HOWEVER, THEY WERE UNABLE TO REPRODUCE THE REPORTED FAULT.
IT WAS REPORTED THAT THERE WAS AN INCIDENT IN THE NICU INVOLVING AN AIR-IN-LINE SENSOR THAT REPORTEDLY DID NOT FUNCTION AS EXPECTED. CLINICAL STAFF IDENTIFIED THAT AN AIR BUBBLE WAS ABOUT TO BE INFUSED. AT THE 07:30 SHIFT CHANGE, THE WRITER COMPLETED TRANSFER OF ACCOUNTABILITY WITH THE NIGHT NURSE FOR THE INFANT IN BED. THE BABY WAS IN AN INCUBATOR WITH D10W INFUSING VIA IV IN THE RIGHT HAND AT 3.8ML/HR. THE IV TUBING AND BURETROL WERE NOT DRY; ADDITIONAL FLUID WAS ADDED TO THE BURETROL IN THE PRESENCE OF THE NIGHT NURSE. THE IV SITE WAS DRY, INTACT, AND WITHOUT REDNESS OR SWELLING. AT 08:53, BLOOD WORK WAS DRAWN AND A BEDSIDE GLUCOSE CHECK SHOWED 4.4MMOL/L. AT 09:06, WHEN PREPARING TO SALINE-LOCK THE IV, THE WRITER OBSERVED APPROXIMATELY 15 CM OF AIR IN THE IV TUBING ABOUT TO REACH THE INFANT¿S HAND, ALONG WITH SEVERAL OTHER SMALLER AIR POCKETS (2¿3 CM EACH, ABOUT 5¿6 SECTIONS). THE IV WAS IMMEDIATELY SALINE-LOCKED. THROUGHOUT, THE INFANT REMAINED VITALLY STABLE WITH NORMAL BLOOD PRESSURE, NO RESPIRATORY DISTRESS, AND GOOD COLOR AND TONE. THE HOSPITAL BIOMED HAS COMPLETED INITIAL TESTING OF THE DEVICE; HOWEVER, THEY WERE UNABLE TO REPRODUCE THE REPORTED FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667254 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |