MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD (BECTON DICKINSON) ALARIS INFUSION PUMP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8100

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908)

Event Date 04/26/2022

Event Type  Injury  

Event Description

After induction of anesthesia an infusion of norepinephrine was used and then the channel was 'paused' as the patient's blood pressure was corrected.Later it was noticed that the norepinephrine was free flowing through the pump.The pump was then turned off and disconnected from the patient.Medications to correct the hypertension were given but excessive blood pressure caused cardiac collapse.Fda safety report id# (b)(4).

• Brand Name: BD (BECTON DICKINSON) ALARIS INFUSION PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 14267170
• MDR Text Key: 290682719
• Report Number: MW5109475
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native