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

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Oversedation (1990); Low Oxygen Saturation (2477)

Event Date 03/03/2021

Event Type  Injury  

Event Description

A patient was taken to the operating room for a planned hemorrhoidectomy under sedation.He had received 2mg versed prior to transport.He moved himself to the prone position on the operating room bed.Monitors, nasal cannula oxygen and a propofol infusion were connected.The infusion was programmed to run at 35 mcg/kg/min.While positioning was continuing, the patient became unresponsive and spo2 dropped.It was then noted that the 50 ml propofol bottle was empty and that the patient had received an excess dose of propofol leading to apnea.Pump used: alaris smart pump investigation: pump was programmed and loaded correctly by the user.No obvious reason apparent for why fluid would free flow.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 11462301
• MDR Text Key: 239448600
• Report Number: MW5099919
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR