MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION

Model Number 2426-0500

Device Problem Material Deformation (2976)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/04/2020

Event Type  Death  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that tubing model #2426-0500 failed during a code.A patient was admitted to the emergency department [ed] requiring cpr compressions and was coded multiple times throughout the day.An epinephrine drip infusing at 20mcg/kg/min stopped working after 10 minutes of use and the pump started alarming.The pump was opened and the tubing appeared dilated [ballooning] between the blue connector and the safety clamp.This lead to a 15-20 second delay in care while the tubing was changed out to prime a new epinephrine drip.The epinephrine was infusing through a central line.The patient expired on (b)(6) 2020.The primary cause of death was cardiac arrest and no autopsy will be performed.The medical center stated, "the patient's death was already happening, the event was a tiny piece of that puzzle.It is unlikely the event contributed to the patient's death.".

Manufacturer Narrative

The customer¿s report of the silicone segment of the tubing appeared dilated [ballooning] between the upper and lower fitment was confirmed by visual inspection.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.The balloon was identified to be located just below the upper fitment of the tubing.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.Functional testing of previous complaints with the failure mode of ¿balloon/bulge in silicone tubing segment¿ has been performed by injecting an iv push bolus both with and without first clamping the tubing to prevent backflow.Ballooning was not replicated in any clamped testing but has been replicated in unclamped testing when the tubing had been visually observed to be compromised (from previous ballooning).Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that a primary tubing failed during a code, and the patient expired.A patient was admitted to the emergency department [ed] requiring cpr compressions and was coded multiple times throughout the day.An epinephrine drip that was infusing via central line at 20mcg/kg/min alarmed and stopped after 10 minutes of use.The pump door was opened and the tubing appeared dilated [ballooning] between the upper and lower fitment, which lead to a 15-20 second delay in care while the tubing was changed and a new epinephrine drip was primed.The patient expired on (b)(6) 2020.The primary cause of death was cardiac arrest and no autopsy was performed.The medical center stated, "the patient's death was already happening, the event was a tiny piece of that puzzle.It is unlikely the event contributed to the patient's death.".

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9750683
• MDR Text Key: 180751083
• Report Number: 9616066-2020-00567
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 7613203020992
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 19123168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, 8015, THERAPY DATE UNKNOWN; 8100, 8015, THERAPY DATE UNKNOWN
• Patient Outcome(s): Death
• Patient Age: 69 YR