ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-126617
- Event Type
- Malfunction
- Date Received
- October 27, 2025
- Date of Event
- September 21, 2025
- Report Date
- November 20, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
OMIT: OTHER OCCUPATION, REPORT SOURCE OTHER, B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. CORRECTION: DESCRIBE EVENT OR PROBLEM, INITIAL REPORTER OCCUPATION, REPORT SOURCE, MANUFACTURING LOCATION. ADDITIONAL INFORMATION: OTHER RELEVANT HISTORY, CONCOMITANT MED PROD DATA, DEVICE EVAL BY MANUFACTURER?, 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 EVENT OF "OVER INFUSION - MAGNESIUM SULFATE" COULD NOT BE CONFIRMED THROUGH LABORATORY TESTING OR LOG REVIEW. THE PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION. DURING THE INTERNAL AND EXTERNAL INSPECTION OF THE SUSPECT PUMP MODULE, THERE WERE NO ISSUES OR ANOMALIES IDENTIFIED DURING THE INSPECTION OF THE DEVICE. ALL PARTS INSPECTED WERE MANUFACTURED BY BD. FIVE TRIALS WERE CONDUCTED AT INFUSION RATES OF 0.1ML/H, 1ML/H, 10ML/H, 100ML/H, AND 999ML/H IN ACCORDANCE WITH THE TIMED RATE ACCURACY PRODUCT ANALYSIS PROCEDURE (1503-001-006 (03), DIR# (B)(4). NO INSTANCES OF UNREGULATED FLOW WERE OBSERVED. RATE ACCURACY TESTING WAS PERFORMED ON THE SUSPECT PUMP MODULE. THE DEVICE WAS FOUND TO BE DELIVERING FLUID WITHIN SPECIFICATION. SPRING FUNCTIONAL TESTS OBSERVED NO ISSUES, AND ALL TESTS PASSED, INDICATING THE OCCLUDERS AND SPRINGS WERE FUNCTIONING AS INTENDED. A REVIEW OF THE LOGS WAS CONDUCTED, AND IT WAS OBSERVED THAT ON THE DATE MENTIONED BY THE FACILITY (21SEP2025), THE SUSPECTED PUMP MODULE WAS CONNECTED AT 12:01 PM TO PCU S/N (B)(6) ON CHANNEL B, WITH AN AIL BOLUS LIMIT OF 250 MICRO L. AT 12:32 PM, THE PUMP MODULE WAS PROGRAMMED WITH A RATE OF 50 ML/H AND A VTBI OF 500 ML (INFUSION DURATION OF 10 HOURS), AND THE INFUSION BEGAN. AT 5:24 PM, THE PUMP MODULE WAS SWITCHED TO ANOTHER CHANNEL (CHANNEL B) AND WAS QUICKLY RETURNED TO ITS PREVIOUS CHANNEL (CHANNEL C). THE INFUSION WAS PAUSED, THEN RESTARTED, AND AT 6:58 PM IT WAS REPROGRAMMED WITH A RATE OF 999 ML/H AND A VTBI OF 450 ML (INFUSION DURATION OF 27 MINUTES). THE INFUSION STARTED, AND AT 7:12 PM THE CHANNEL OFF KEY WAS PRESSED, STOPPING THE INFUSION. AT 7:15 PM, THE PUMP MODULE WAS PROGRAMMED WITH A RATE OF 50 ML/H AND A VTBI OF 50 ML (INFUSION DURATION OF 1 HOUR), AND THE INFUSION BEGAN. AT 7:27 PM, THE RATE WAS CHANGED TO 25 ML/H AND THE VTBI TO 39.82 ML (INFUSION DURATION OF 95.57 MINUTES). THE INFUSION STARTED, AND AT 7:42 PM THE CHANNEL OFF KEY WAS PRESSED. THE BD ALARIS SYSTEM WITH GUARDRAILS SUITE MX V12.3.2 USER MANUAL STATES THAT TO PREVENT A POTENTIAL UNCONTROLLED FLOW (FREE-FLOW) CONDITION, ENSURE THAT NO EXTRANEOUS OBJECT (FOR EXAMPLE, BEDDING, TUBING, GLOVE) IS ENCLOSED OR CAUGHT IN THE PUMP MODULE DOOR. TO PREVENT A POTENTIAL UNCONTROLLED FLOW (FREE-FLOW CONDITION), DO NOT USE AN INFUSION MODULE IF IT IS DAMAGED IN ANY WAY OR DOES NOT APPEAR TO BE FUNCTIONING AS EXPECTED. UNCONTROLLED FLOW (FREE-FLOW) CAN RESULT IN PATIENT HARM. THE PUMPING MECHANISM WAS DISASSEMBLED DURING THE INTERNAL INSPECTION. THE MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO DCHU, REPAIR CENTER, OR THE FACILITY. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED EVENT OF "OVER INFUSION - MAGNESIUM SULFATE" COULD NOT BE DETERMINED THROUGH LABORATORY TESTING OR LOG REVIEW. THE PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION. 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 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.
IT WAS REPORTED THERE WAS AN OVER INFUSION OF MAGNESIUM SULFATE TO A PREGNANT PATIENT WITH PREECLAMPSIA. THE MAGNESIUM SULFATE (20,000 MG/500 ML) WAS INTENDED TO INFUSE AT A RATE OF 50ML/HOUR, HOWEVER IT WAS FOUND THAT 236.1ML HAD INFUSED WITHIN 14 MINUTES. FOLLOWING THE INFUSION, THE PATIENT EXPERIENCED SENSATION OF BEING "VERY HOT" WHICH RESOLVED WITH DISCONTINUATION OF MAGNESIUM SULFATE. MAGNESIUM LEVEL AND EKG ORDERED ¿ MAGNESIUM LEVEL 7.4 MG/DL WHICH WAS CITED AS ¿NORMAL THERAPEUTIC RANGE FOR PREECLAMPSIA¿. EKG WAS READ BY CARDIOLOGIST AS NORMAL. THE REPORTED PATIENT OUTCOME WAS "BOTH MOM AND BABY ARE STABLE."
IT WAS REPORTED THERE WAS AN OVER INFUSION OF MAGNESIUM SULFATE TO A PREGNANT PATIENT WITH PREECLAMPSIA. THE MAGNESIUM SULFATE (20,000 MG/500 ML) WAS INTENDED TO INFUSE AT A RATE OF 50ML/HOUR, HOWEVER IT WAS FOUND THAT 236.1ML HAD INFUSED WITHIN 14 MINUTES. FOLLOWING THE INFUSION, THE PATIENT EXPERIENCED SENSATION OF BEING "VERY HOT" WHICH RESOLVED WITH DISCONTINUATION OF MAGNESIUM SULFATE. MAGNESIUM LEVEL AND EKG ORDERED ¿ MAGNESIUM LEVEL 7.4 MG/DL WHICH WAS CITED AS ¿NORMAL THERAPEUTIC RANGE FOR PREECLAMPSIA¿. EKG WAS READ BY CARDIOLOGIST AS NORMAL. THE REPORTED PATIENT OUTCOME WAS "BOTH MOM AND BABY ARE STABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2351499 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female |