MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. BD ALARIS INFUSION PUMP AND MODULE; PUMP, INFUSION

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Pumping Problem (3016)

Patient Problems Stroke/CVA (1770); Oversedation (1990); Irritability (2421); Respiratory Failure (2484); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/14/2022

Event Type  Injury  

Event Description

Patient admitted for stroke on (b)(6) 2022 and received tenecteplase at 1400.On (b)(6) 2022 at 0300 he became agitated and was started on a dexmedetomidine drip.Drip initiated at 0326 at a rate of approximately 35 ml/hr.Two rns saw this rate (both in mcg and ml).At 0342 second rn was still assisting in room and got air in line warning on pump, when the pump was checked the dexmedetomidine 800mcg/200ml bag was completely empty.Patient received 800mcg/200 ml dexmedetomidine in 16 minutes (a rate of approximately 800 ml/hr).At this point the patient had snoring respirations and was unarousable to pain.Md contacted and instructed nurse to monitory closely for need to intubate, but not indicated at this time.Contacted poison control and only treatment is to wait it out.Patient intubated at 0432 0432.Acute respiratory failure secondary to stroke as well as possible aspiration pneumonia and pre-existing upper respiratory infection with rsv.Pt uses cpap at home he did have hypercapnia as well as increasing secretions and therefore was recently intubated.

• Brand Name: BD ALARIS INFUSION PUMP AND MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 16077489
• MDR Text Key: 306526502
• Report Number: MW5114092
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/02/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEXMEDETOMIDINE; TENECTEPLASE
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American