MAUDE Adverse Event Report: CAREFUSION NON-VENTED GRAVITY BLOOD SET

Model Number 10010903

Device Problems Obstruction of Flow (2423); No Flow (2991)

Patient Problem Death (1802)

Event Date 11/20/2019

Event Type  Death  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the iv tubing set would not flow while resuscitating a hemodynamically unstable patient with a dissecting aaa (abdominal aortic aneurysm) in the or during a massive transfusion protocol.While trouble shooting, it was discovered that the tubing set remained sealed in two separate locations when the clamps were opened, preventing the administration of blood and medications to the patient.The patient was critically ill, unable to be resuscitated and expired during the event.

Manufacturer Narrative

Two photos were provided by the customer.The first photo shows the distal portion of the set connected to an extension set and a standalone stopcock on top of the bed sheet.The second photo shows a puddle of what appears to be a blood spill.However no issues were observed.The root cause of this failure was not identified.

Event Description

It was reported that the iv tubing set would not flow while resuscitating a hemodynamically unstable patient with a dissecting aaa (abdominal aortic aneurysm) in the or during a massive transfusion protocol.While trouble shooting, it was discovered that the tubing set remained sealed in two separate locations when the clamps were opened, preventing the administration of blood and medications to the patient.The patient was critically ill, unable to be resuscitated and expired during the event.

• Brand Name: NON-VENTED GRAVITY BLOOD SET
• Type of Device: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9498820
• MDR Text Key: 172184344
• Report Number: 9616066-2019-03714
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: 7613203020879
• Combination Product (y/n): N
• PMA/PMN Number: K882302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10010903
• Device Catalogue Number: 10010903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR