ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-148447
- Event Type
- Malfunction
- Date Received
- January 9, 2026
- Date of Event
- November 22, 2025
- Report Date
- January 30, 2026
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
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. ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED THAT THE ONE OF THE LARGE VOLUME PUMP MODULES HAD OVER INFUSED WHICH WAS NOT IDENTIFIED DURING THE CUSTOMER CALL. THE TECH SUPPORT ESCALATED THE CASE TO DCHU. HOWEVER, THERE WAS NO SUFFICIENT SAMPLE TO ADDRESS THE ISSUE. 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: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION: IMDRF ANNEX A, G, B, C AND D 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 ISSUE OF AN OVER INFUSION OF HEPARIN WAS NOT CONFIRMED THROUGH REVIEW OF THE LOGS ALONE AND DEVICES WERE NOT RECEIVED FOR THIS INVESTIGATION. THE FACILITY ALSO REQUESTED ANSWERS TO SPECIFIC QUESTIONS ASSOCIATED WITH THEIR DEVICE LOGS. THE INITIAL INFUSION FOR AN UNKNOWN FLUID (SUSPECTED TO BE NORMAL SALINE) WAS PROGRAMMED ON PUMP MODULE S/N (B)(6) ON (B)(6) 2025 AT 10:43 PM, AT A RATE OF 75 ML AND A VOLUME TO BE INFUSED (VTBI) OF 1000 ML. THE INITIAL INFUSION FOR AN UNKNOWN DRUG (SUSPECTED TO BE HEPARIN) AT A CONCENTRATION OF 25000 UNITS/250 ML WAS PROGRAMMED ON PUMP MODULE S/N (B)(6) ON (B)(6) 2025, AT 10:49 PM, AT A RATE OF 9.5 ML/HR (CALCULATING A DOSE OF 950 UNITS/HR) AND A VTBI OF 250 ML. A REVIEW OF THE PCU ERROR LOGS COULD NOT BE PERFORMED SINCE THEY WERE NOT PROVIDED BY THE FACILITY. ON (B)(6) 2025, AT 2:18 AM, AN AIR-IN-LINE (AIL) ALARM WAS OBSERVED ON THE PUMP MODULE S/N (B)(6), THE INFUSION WAS RESTARTED AT 2:20 AM BEFORE A SECOND AIL ALARM. AT 2:21 AM, THE INFUSION WAS RESTARTED, THE DOOR WAS OPENED, AND THE UNIT WAS CHANNELED OFF. AT 2:27 AM, THE INFUSION ON PUMP MODULE S/N (B)(6) WAS PAUSED, A SAFETY CLAMP OPEN ALARM WAS OBSERVED LASTING TWO (2) SECONDS. THE DOOR WAS THEN CLOSED, AND THE UNIT WAS CHANNELED OFF. THE VOLUME INFUSED FOR THE SUSPECTED HEPARIN INFUSION (PUMP MODULE S/N (B)(6)) WAS RECORDED AT 34.486 ML. IT IS NOT POSSIBLE TO DETERMINE WHAT THE ACTUAL VOLUME IS WITHIN AN IV CONTAINER AT THE START AND ENDING OF AN INFUSION FROM A REVIEW OF A PUMP MODULE OR A PCU EVENT LOG. THIS IS NOT A FUNCTION OF THE EVENT LOG; IT ONLY CAN REFLECT THE INPUTTED INFORMATION IT RECEIVES EITHER MANUALLY OR REMOTELY WITH RESPECT TO VOLUME TO BE DELIVERED. THE FACILITY HAD QUESTIONS REGARDING SPECIFIC SECTIONS OF THE DEVICE LOG. THE ANSWERS ARE SHOWN BELOW: SEQ 409 & 410: ¿EXTERNAL_CONTROL_EVENT¿ IS AN AUTOMATIC EVENT THAT SETS THE PERIODIC MESSAGE INTERVAL FOR EXTERNAL COMMUNICATION. SEQ 407: THE ¿AVA_EVENT_PCU¿ MESSAGE PRECEDES ANY AUDIO ALARM OR VISUAL EVENT THAT OCCURS ON THE PCU. SEQ 408: THE ALARM OCCURRING ON PUMP MODULE S/N (B)(6) (SUSPECTED TO BE INFUSING NORMAL SALINE) WAS FOR AN AIR-IN-LINE ALARM ON (B)(6) 2025 AT 2:18 AM. SEQ 403: PUMP MODULE S/N (B)(6) (SUSPECTED TO BE INFUSING HEPARIN) ALARMED ON (B)(6) 2025, AT 2:27 AM, FOR A SAFETY CLAMP OPEN (LASTING APPROXIMATELY 2 SECONDS), FOLLOWED BY A DOOR CLOSED ALARM. THE UNIT WAS THEN CHANNELED OFF. SEQ 415: ¿BLOCK_STEP_DATA¿ INDICATES THE INFUSION PARAMETERS FOR THE CURRENT PROGRAMMED INFUSION. THIS CONFIRMS THAT THE RATE WAS PROGRAMMED AT 9.5 ML/HR. AFTER SEQ 415: THE LOG DOES NOT SHOW ANY INCREASE OR DECREASE IN THE PROGRAMMED RATE DURING THE TIME OF THE INCIDENT. INSPECTION AND TESTING OF THE REPORTED DEVICES COULD NOT BE PERFORMED SINCE THEY WERE NOT RETURNED BY THE FACILITY FOR INVESTIGATION. THE ALARIS SYSTEM USER MANUAL (V12.1), STATES WITHIN WARNINGS AND CAUTIONS, ¿TO PREVENT A POTENTIAL FREE-FLOW CONDITION, ENSURE THAT NO EXTRANEOUS OBJECT (FOR EXAMPLE, BEDDING, TUBING, GLOVE) IS ENCLOSED OR CAUGHT IN THE PUMP MODULE DOOR.¿ THE ALARIS SYSTEM USER MANUAL, DOOR KEYPAD ARTWORK, AND THE QUICK REFERENCE GUIDE REMIND THE USER TO ¿CLOSE THE ROLLER CLAMP BEFORE OPENING THE DOOR¿. THE DEVICES WERE REPORTEDLY IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED OVER INFUSION OF HEPARIN WAS NOT DETERMINED. NO ERRORS OR MALFUNCTIONS WERE CONFIRMED THROUGH REVIEW OF THE LOGS, AND THE EVENT COULD NOT BE REPLICATED SINCE THE DEVICES WERE NOT RECEIVED FOR INVESTIGATION. THE FACILITY HAD SPECIFIC QUESTIONS REGARDING THE LOGS, AND THEY WERE ANSWERED ACCORDINGLY. 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 ONE OF THE LARGE VOLUME PUMP MODULES HAD OVER INFUSED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THE CUSTOMER LATER PROVIDED THE FOLLOWING INFORMATION: THE EVENT OCCURRED ON 22NOV2025 AT 1050PM. THE INFUSION WAS A HEPARIN DRIP WITH AN INTENDED RATE OF INFUSION OF 9.5ML/HR, AT A DOSE RATE OF 950UNITS/HR. IT WAS A TITRATABLE DRIP BASED ON AN APTT LAB RESULT AND HAD A BAG VOLUME OF 250ML. THE CONCENTRATION WAS (B)(4) UNITS IN DEXTROSE 5% 250ML. THERE WAS ALSO A SODIUM CHLORIDE SOLUTION THAT WAS SET UP ON THE OTHER CHANNEL AND WAS INFUSING THROUGH THE SECOND SALINE LOCK. THE HEPARIN AND NS WERE NOT INFUSING THROUGH THE SAME CHANNEL, AND NOT THROUGH THE SAME IV. IT WAS NOTED THAT 250ML HAD INFUSED IN 4 HOURS. THE CUSTOMER ALSO HAD THE FOLLOWING QUESTIONS REGARDING THE EVENT: " I JUST WANT TO CONFIRM THAT THE DRIP WAS INFUSING AT 9.5 ML/HR. THAT¿S THE ONLY INFORMATION WE NEED. WE ALREADY HAVE DOCUMENTATION SHOWING THE PUMP DID NOT MALFUNCTION. 1. SEQ 409 & 410: WHAT DOES ¿EXTERNAL_CONTROL_EVENT¿ MEAN IN THE DESCRIPTION? 2. SEQ 407: WHAT DOES ¿AVA_EVENT_PCU¿ MEAN IN THE DESCRIPTION? 3. SEQ 408: DESCRIPTION SHOWS ¿PUMP_ALARMED¿; DETAILS SHOW ¿PRIMARY VOLUME INFUSED=269.442.¿ DID THE PUMP ALARM BECAUSE THE HEPARIN BAG WAS EMPTY OR FOR ANOTHER REASON? 4. SEQ 403: DESCRIPTION SHOWS ¿PUMP_ALARMED.¿ CAN YOU CONFIRM WHY THE PUMP ALARMED? 5. SEQ 415: WHAT DOES ¿BLOCK_STEP_DATA¿ MEAN? DETAILS SHOW ¿RATE: 9.5.¿ DOES THIS CONFIRM THE RATE WAS SET AT 9.5 ML/HR? 6. AFTER SEQ 415: DOES THE LOG INDICATE THE RATE WAS NOT MANUALLY INCREASED BEFORE THE HEPARIN BAG WAS COMPLETED?"
IT WAS REPORTED THAT ONE OF THE LARGE VOLUME PUMP MODULES HAD OVER INFUSED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THE CUSTOMER LATER PROVIDED THE FOLLOWING INFORMATION: THE EVENT OCCURRED ON (B)(6) 2025 AT 1050PM. THE INFUSION WAS A HEPARIN DRIP WITH AN INTENDED RATE OF INFUSION OF 9.5ML/HR, AT A DOSE RATE OF 950UNITS/HR. IT WAS A TITRATABLE DRIP BASED ON AN APTT LAB RESULT AND HAD A BAG VOLUME OF 250ML. THE CONCENTRATION WAS 25,000 UNITS IN DEXTROSE 5% 250ML. THERE WAS ALSO A SODIUM CHLORIDE SOLUTION THAT WAS SET UP ON THE OTHER CHANNEL AND WAS INFUSING THROUGH THE SECOND SALINE LOCK. THE HEPARIN AND NS WERE NOT INFUSING THROUGH THE SAME CHANNEL, AND NOT THROUGH THE SAME IV. IT WAS NOTED THAT 250ML HAD INFUSED IN 4 HOURS. THE CUSTOMER ALSO HAD THE FOLLOWING QUESTIONS REGARDING THE EVENT: " I JUST WANT TO CONFIRM THAT THE DRIP WAS INFUSING AT 9.5 ML/HR. THAT¿S THE ONLY INFORMATION WE NEED. WE ALREADY HAVE DOCUMENTATION SHOWING THE PUMP DID NOT MALFUNCTION. 1. SEQ 409 & 410: WHAT DOES ¿EXTERNAL_CONTROL_EVENT¿ MEAN IN THE DESCRIPTION? 2. SEQ 407: WHAT DOES ¿AVA_EVENT_PCU¿ MEAN IN THE DESCRIPTION? 3. SEQ 408: DESCRIPTION SHOWS ¿PUMP_ALARMED¿; DETAILS SHOW ¿PRIMARY VOLUME INFUSED=269.442.¿ DID THE PUMP ALARM BECAUSE THE HEPARIN BAG WAS EMPTY OR FOR ANOTHER REASON? 4. SEQ 403: DESCRIPTION SHOWS ¿PUMP_ALARMED.¿ CAN YOU CONFIRM WHY THE PUMP ALARMED? 5. SEQ 415: WHAT DOES ¿BLOCK_STEP_DATA¿ MEAN? DETAILS SHOW ¿RATE: 9.5.¿ DOES THIS CONFIRM THE RATE WAS SET AT 9.5 ML/HR? 6. AFTER SEQ 415: DOES THE LOG INDICATE THE RATE WAS NOT MANUALLY INCREASED BEFORE THE HEPARIN BAG WAS COMPLETED?"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 82231 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |