FDA Adverse Event Injury Summary report: N

ALARIS SYSTEM

MDR report key: 23752943 · Received December 8, 2025

Report

Report Number: 2016493-2025-141595
Event Type: Injury
Date Received: December 8, 2025
Date of Event: September 19, 2025
Report Date: November 18, 2025
Manufacturer: CAREFUSION SD
Product Code: FRN
PMA / PMN Number: K133532
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT DEVICE HAD PROGRAMMING ERROR. THE DEVICE WAS NOT RETURNED 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENT WAS RECEIVING LEVOPHED AT A RATE OF 0.04 MCG/KG/MIN AND PRECEDEX AT 0.4 MCG/KG/HR. THE PATIENT SUDDENLY BECAME AGITATED, AND AFTER ADMINISTERING A FENTANYL BOLUS, THE CLINICIAN ATTEMPTED TO INCREASE THE PRECEDEX DOSE. HOWEVER, THE LEVOPHED WAS MISTAKENLY INCREASED FROM 0.04 TO 0.5, AS THE CLINICIAN BELIEVED THEY WERE ADJUSTING THE PRECEDEX. BLOOD PRESSURE WAS BEING MONITORED EVERY 15 MINUTES, AND ON THE NEXT CHECK, THE PATIENT¿S BLOOD PRESSURE HAD RISEN FROM 103/54 TO 182/106. THE CLINICIAN THEN REALIZED THE ERROR AND IMMEDIATELY TITRATED THE LEVOPHED BACK TO 0.04. THE INCORRECT LEVOPHED DOSAGE WAS MAINTAINED FOR APPROXIMATELY 20 MINUTES BEFORE THE CLINICIAN TITRATED THE MEDICATION BACK TO ORDERED RATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2814609	ALARIS SYSTEM	PUMP, INFUSION	FRN	CAREFUSION SD	8015

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention