MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8100

Device Problem Device Alarm System (1012)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 01/29/2023

Event Type  Death  

Manufacturer Narrative

Bd technical support troubleshooting with customer over the phone.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.Device was not returned to manufacturing facility.

Event Description

It was reported that a patient was admitted to the intensive care unit (icu) due to low blood pressure (89/55).A titratable infusion of levophed (30mcg/min) was started along with vasopressin at 0.04units/min.It was reported that during the day, the patient¿s blood pressure became "unstable" and neo-synephrine (titratable dose) was also started.The patient was then transported from the icu to mri/ct scan department for spine imaging tests.Upon arrival in the mri, the patient was transferred from the hospital bed to the mri table.The two vasopressor infusions were transferred from the alaris infusion system to another infusion pump that is mri-compatible.After completing the mri procedure, the patient was transferred back to the hospital bed and the infusions were transferred from the mri-compatible infusion pump back to the alaris infusion system.However, it was reported that the nurse was unable to turn on the alaris pcu.The nurse then requested the transport aid to go to the emergency department to retrieve another infusion device.The nurse then reportedly left the mri with the patient to return to icu.While waiting for the elevator, the patient reportedly "decompensated." the nurse then started cardiopulmonary resuscitation, which was continued while in the elevator and until they reached the icu.The patient was given 1mg of epinephrine and a return of spontaneous circulation (rosc) was achieved.The patient was reportedly intubated.The event occurred on (b)(6) 2023 at 1830.It was then reported that the patient passed on (b)(6) 2023 and according to the hospital's patient safety director, the death was attributed to "medication error due to the nurse not placing the patient back on the mri (compatible) pump for the required medications the patient was being administered.".

Event Description

It was reported that a patient was admitted to the intensive care unit (icu) due to low blood pressure (89/55).A titratable infusion of levophed (30mcg/min) was started along with vasopressin at 0.04units/min.It was reported that during the day, the patient¿s blood pressure became "unstable" and neo-synephrine (titratable dose) was also started.The patient was then transported from the icu to mri/ct scan department for spine imaging tests.Upon arrival in the mri, the patient was transferred from the hospital bed to the mri table.The two vasopressor infusions were transferred from the alaris infusion system to another infusion pump that is mri-compatible.After completing the mri procedure, the patient was transferred back to the hospital bed and the infusions were transferred from the mri-compatible infusion pump back to the alaris infusion system.However, it was reported that the nurse was unable to turn on the alaris pcu.The nurse then requested the transport aid to go to the emergency department to retrieve another infusion device.The nurse then reportedly left the mri with the patient to return to icu.While waiting for the elevator, the patient reportedly "decompensated." the nurse then started cardiopulmonary resuscitation, which was continued while in the elevator and until they reached the icu.The patient was given 1mg of epinephrine and a return of spontaneous circulation (rosc) was achieved.The patient was reportedly intubated.The event occurred on 29 january 2023 at 1830.It was then reported that the patient passed on (b)(6) 2023 and according to the hospital's patient safety director, the death was attributed to "medication error due to the nurse not placing the patient back on the mri (compatible) pump for the required medications the patient was being administered.".

Manufacturer Narrative

Correction: it was determined through investigation of the returned devices that the initially reported suspect device reported under manufacturer report number 2016493-2023-132771 is a concomitant.Please refer to manufacturer report number 2016493-2023-121250, which captured the correct suspect device per investigation report.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 16596019
• MDR Text Key: 311816635
• Report Number: 2016493-2023-132771
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8100(3)
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 80 KG