MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8541

Device Problem Disconnection (1171)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  Death  

Manufacturer Narrative

Device manufacturer address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a clearlink system continu-flo solution set was disconnected from the oxygen tubing.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: upon follow up it was reported, the patient was admitted to the hospital (unknown date).The patient was receiving 15 liters of oxygen via a hi-flow non-rebreathing mask.A central monitoring alarm was generated from the patient¿s room.The nurse found the oxygen tubing unplugged from the oxygen wall mount and held by the patient.The nurse traced the entire length of the oxygen tubing and found that the end was plugged into one of the ports of the clearlink set.It was further reported "they were infusing tko (to keep open) into iv".It was reported the patient ¿coded¿ and subsequently passed away.The cause of death was not reported.It was not reported if an autopsy was performed.D4: an invalid lot number was provided: 1084397.H10: the likely cause of the reported event was associated with user error.The indication for use for continue -flo sets is: 'for the administration of fluids from a container into the patient's vascular system through a vascular access device'.Use of the clearlink continu-flo solution set with other machines represents use of a product or system in a way not intended by the manufacturer and can result from misuse.There is a caution statement on the label stating: "do not connect any compressed gas device to intravenous injection sites".The label also provides priming and flow rate setting instructions that would only apply to liquids.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12367534
• MDR Text Key: 268139461
• Report Number: 1416980-2021-05229
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8541
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR