MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS PUMP INFUSION SET; SET, ADMINSTRATION, INTRAVASCULAR

Model Number 2426-0500

Device Problems Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)

Patient Problems Death (1802); Loss Of Pulse (2562)

Event Date 12/24/2020

Event Type  Death  

Event Description

A (b)(6) yo female admitted on (b)(6) 2020 for covid pneumonia, hyperkalemia, respiratory failure, dm2, heart failure w/ preserved ef, and encephalopathy.Pulse ox ~ 88%.Placed on non-rebreather, then required intubation on (b)(6) for sats in the 70%.She was started on decadron.Creat cl was 40 so remdesivir was held.Convalescent plasma given.On (b)(6) at 0159 o2 sat 75 ¿ 80 on vent, maximum vent settings, high peep, fio2 100.Fluid overload ¿ given lasix.Patient was prone.At 0737, in preparation for changing the propofol infusion, a bottle was primed and attached to the main ns iv tubing below the pump and clamped.The primary rn told another rn hat the propofol may run out and to keep a listen for the pump to beep.The new bottle was ready to be placed on the pump when this happened.Bp ~169/67 until 0841 when it dropped to 32/21.O2sat was 75%.The charge nurse noted the patient's hr to be 64 (had been 75 ¿ 85).The respiratory therapist was in the room.The charge nurse asked the rt to check for a pulse.Patient had no pulse: pulseless electrical activity (pea) arrest.Acls done with alternating return of pulse and pea until 1012 when the patient expired.Primary rn made a statement that the whole propofol bottle was empty at the beginning of the code.The roller clamp was noted to be open.Unsure if the roller clamp status is a product defect or human error.Patient also had dopamine, epinephrine, levophed, and vasopressin drips hanging.During interviews, staff said the tubing for propofol had leaked on the floor on at least two prior occasions when a new bottle was set up for change out.These times the tubing was not connected to the patient.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINSTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 11116507
• MDR Text Key: 225333185
• Report Number: MW5098645
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/30/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 117