MAUDE Adverse Event Report: CARDIACASSIST, INC. SHIP KIT, OXYGENATOR, TANDEMLUNG; OXYGENATORY, CARDIOPULMONARY BYPASS

Model Number 5160-0000

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

Cardiacassist received a report that a series of air bubbles was identified in the circuit during a procedure utilizing the tandemlung oxygenator.It was reported that the perfusionist utilized tubing clamps initially to remove air from the oxygenator and was immediately told to stop and instead use the heal of his hand.This action was able to remove all air from the line, however when the circuit was brought up to do the wet-to-wet connection (not yet connected to arterial cannula), additional air in the line was identified and the user decided to swap out for a fresh circuit.There was no patient injury reported for this event.

Manufacturer Narrative

Patient ethnicity was not provided.Cardiacassist inc.Manufactures the tandemlung oxygenator.The reported event occurred in (b)(6), united states.No patient injury was reported.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10.The complained unit was returned to livanova for investigation.Visual inspection showed signs of fluid buildup in the blood out/gas in cap.This is believed to have been fluid ingress from the device being submerged in the shipping container.The fluid was removed from the cap, which was then successfully primed, and the leak test showed no signs of leaks or air in the circuit.A tlo 00605701 test was performed and results were as expected from a functional and mechanical integrity standpoint.The issue could not be confirmed and the cause of difficult priming experienced by the users could not be determined.As the issue was not confirmed, a root cause for the air in the circuit could not be determined.However, it is recommended to use normal saline solution during priming.According to the livanova representative, the perfusionist did not follow the proper procedures when priming the circuit which may have resulted in air induced into the oxygenator.In the oxygenator dfu (cp-pit-7000-0161) section 7.2.3-7.2.5, it states: "allow saline to fill the pump and oxygenator and flush the air out the end of the tubing.Approximately 240cc of saline (four 60 cc syringes) will be needed to prime the circuit.Note: do not submerge the oxygenator.Liquid should never be introduced into the gas pathways.Tap the oxygenator and pump to expel all air from the circuit.The tubing may also be connected to a reservoir and saline pumped through the circuit at 1-3 lpm to remove any additional air.When all air has been successfully removed and the circuit has been fully primed, clamp the pump inflow and oxygenator outflow tubing approximately 1¿ from the end of the tubing." failure to follow these instructions may lead to air remaining in the line.A review of the dhr for both the oxygenator and priming tray did not identify any deviations or non-conformities relevant to the reported issue.As a root cause could not be determined, no specific corrective action has been identified.Livanova maintains and documents periodic customer event monitoring in order to evaluate actions for product improvement.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: SHIP KIT, OXYGENATOR, TANDEMLUNG
• Type of Device: OXYGENATORY, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST, INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 15007179
• MDR Text Key: 304090430
• Report Number: 2531527-2022-00032
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: 5160-0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 97 KG