ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-109855
- Event Type
- Injury
- Date Received
- September 2, 2025
- Date of Event
- August 4, 2025
- Report Date
- September 18, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
OMIT: B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. CORRECTION: DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION: 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 ISSUE OF THE DEVICE SHUTTING DOWN DURING AN INFUSION WAS NOT CONFIRMED THROUGH REVIEW OF THE LOGS OR REPLICATED DURING DEVICE TESTING. TESTING VIA THE IUI TEST METHOD FOUND NO ISSUES WITH THE SUSPECT OR CONCOMITANT DEVICES. INSPECTION OF THE SUSPECT DEVICE FOUND VERY MINOR SIGNS OF CORROSION WERE OBSERVED ON PINS 14 OF THE RIGHT (MALE) INTER UNIT INTERFACE (IUI) CONNECTOR. IT WAS NOTED THAT CONCOMITANT PCU BATTERY WAS MISSING AND THUS WAS NOT TESTED. AN ATTEMPT WAS MADE TO DOWNLOAD THE LOGS FROM THE ¿AS-RECEIVED¿ DEVICES; HOWEVER, NO CONNECTION WAS ABLE TO BE ESTABLISHED WITH THE PCU. DUE TO THIS, THE SIO BOARD WAS TEMPORARILY REPLACED WITH A KNOWN-GOOD DCHU LAB SIO BOARD. AFTER REPLACING THE BOARD, THE SUSPECT PUMP MODULE AND CONCOMITANT PCU LOGS WERE RETRIEVED. A REVIEW OF THE DEVICE ERROR LOGS DID NOT SHOW ANY ISSUES OR MALFUNCTIONS OCCURRING ON THE DATE OF THE REPORTED INCIDENT. THE SYSTEM WAS POWERED ON (B)(6) 2025 AT 11:02 PM. ¿YES¿ WAS SELECTED FOR NEW PATIENT, ¿YES¿ WAS SELECTED TO CONFIRM THE CURRENT PROFILE ¿LMC JUL 2025V1 ADULT¿. THE INITIAL INFUSION OF NOREPINEPHRINE (LEVOPHED) WAS INITIALLY PROGRAMMED AS A REMOTE ORDER (INTEROPERABILITY) AND STARTED ON (B)(6) 2025 AT 10:58 PM ON THE SUSPECT PUMP MODULE SN (B)(6). THE CONCENTRATION WAS 16 MG/ 250 ML, THE RATE WAS CALCULATED AT 12.5803 ML/HR (WEIGHT-BASED DOSING, DOSE = 0.21 MCG/KG/MIN). THE VOLUME TO BE INFUSED (VTBI) WAS 200 ML. ON (B)(6) 2025, AT 11:10 PM, THE DOSE WAS INCREASED TO THE REPORTED VALUE OF 0.3 MCG/KG/MIN; HOWEVER, THE DOSE WAS TITRATED MULTIPLE TIMES BETWEEN A MINIMUM OF 0.2 MCG/KG/MIN AND A MAXIMUM OF 0.6 MCG/KG/MIN, FROM (B)(6) 2025 AT 11:02 PM, UNTIL 04AUG2025 AT 12:30 PM. THE SYSTEM WAS MANUALLY POWERED OFF BY CHANNELING OFF THE SUSPECT PUMP MODULE ON (B)(6) 2025 AT 11:03 AM. THE SYSTEM WAS POWERED BACK ON AGAIN AT 11:06 AM (RESEMBLING THE REPORTED PERIOD OF TIME WHERE THE PUMP WAS FOUND POWERED OFF). THE INFUSION OF NOREPINEPHRINE WAS PROGRAMMED ONCE AGAIN AS A REMOTE ORDER. THE CONCENTRATION WAS 16 MG/ 250 ML, THE RATE WAS CALCULATED AT 19.17 ML/HR (WEIGHT-BASED DOSING, DOSE = 0.32 MCG/KG/MIN). THE VOLUME TO BE INFUSED (VTBI) WAS 250 ML. THE SYSTEM WAS POWERED OFF ON (B)(6) 2025 AT 12:38 PM. NO OTHER INFUSIONS WERE RECORDED TO HAVE BEEN PROGRAMMED ON THE SUSPECT PUMP MODULE OR ANY OTHER ATTACHED MODULE AFTER THIS TIME. NO MALFUNCTIONS OR CHANNEL DISCONNECT EVENTS WERE OBSERVED THROUGHOUT THE DATE OF THE REPORTED INCIDENT. ROOT CAUSE THE ROOT CAUSE OF THE REPORTED DEVICE SHUT DOWN WAS NOT DETERMINED. NO ERRORS OR MALFUNCTIONS WERE CONFIRMED THROUGH REVIEW OF THE LOGS AND THE EVENT COULD NOT BE REPLICATED DURING DEVICE TESTING. TESTING OF THE CONCOMITANT DEVICE¿S BATTERY WAS NOT PERFORMED SINCE IT WAS NOT RECEIVED FOR THIS INVESTIGATION. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A040502, G02017, C0503, D08 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED 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.
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 THAT THE DEVICE SHUT DOWN DURING AN INFUSION OF LEVOPHED. LEVOPHED WAS ORDERED TO INFUSE AT A RATE OF 0.3MCG/KG/MIN TO MAINTAIN THE PATIENTS BLOOD PRESSURE. THE VOLUME TO BE INFUSED WAS 250ML. PER REPORT, DURING THE DEVICE SHUT DOWN, NO MEDICATION INFUSED TO THE PATIENT FOR APPROXIMATELY 4 TO 6 MINUTES. THE PATIENT'S BLOOD PRESSURE "DROPPED INTO A CRITICAL LEVEL". THERE WAS NO OTHER INFUSIONS RUNNING AT THE TIME OF THE EVENT. THE INFUSION WAS RESTARTED ON A NEW PUMP.
IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING AN INFUSION OF LEVOPHED. LEVOPHED WAS ORDERED TO INFUSE AT A RATE OF 0.3MCG/KG/MIN TO MAINTAIN THE PATIENTS BLOOD PRESSURE. THE VOLUME TO BE INFUSED WAS 250ML. PER REPORT, DURING THE DEVICE SHUT DOWN, NO MEDICATION INFUSED TO THE PATIENT FOR APPROXIMATELY 4 TO 6 MINUTES. THE PATIENT'S BLOOD PRESSURE "DROPPED INTO A CRITICAL LEVEL". THERE WAS NO OTHER INFUSIONS RUNNING AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2087556 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention | 8015. |