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

Model Number	5160-0000
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report that a tandemlife oxygenator failed after a very short period of time while on ecpr (extracorporeal cardiopulmonary resuscitation) support.The oxygenator was changed out to continue the procedure.There was no patient harm reported.
Additional Manufacturer Narrative
A1.-a6.Patient information was not provided.D4.No device identifying information provided.As such, the device lot number is unknown, and the udi and expiration date could not be determined.H4.As the lot number is unknown, manufacture date could not be determined.H10.Livanova manufactures the tandemlife oxygenator.The event occurred in albuquerque, new mexico.There was no report of patient injury.This report describes a malfunction of the tandemlife oxygenator during ecpr support.It is unclear from the report what the exact malfunction of the livanova device was.Through follow-up communication, livanova learned that the patient was on anticoagulants.Additional information about the event has been requested from the customer, however no additional information has been provided at this time.A device evaluation is anticipated, but the device has not yet been returned to livanova.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
D4.Model number: 5160-0000 lot number: 00606347 (b)(4) expiration date: dec 3, 2024 h4.On (b)(6) 2023 h.10 through follow-up communication, livanova learned that the patient was on anticoagulants.Additional information about the event has been requested from the customer, however no additional information has been provided at this time.The complained device was returned to livanova for evaluation.The device was soaked in formalin for 3 days and exterior blood was cleaned off prior to visual inspection.During visual inspection, areas of biological deposit were visible in the middle of the fiber bundle and near the blood inlet connector.A functional inspection was performed.The oxygenator was connected to a circuit with a stock engineering pump and sterile water to collect pressure/flow (hq) data.The returned oxygenator exhibited a pressure drop comparable to the stock engineering device.The hq test performed with a stock engineering pump demonstrated pressure drops across the oxygenator which were comparable to a clean, stock oxygenator.There was no evidence found during testing to suggest clot formation or any failure of the oxygenator.Despite repeated attempts to obtain further information on the case, the site did not provide any additional details on how they assessed that the oxygenator failed or what parameters were monitored to make the determination of oxygenator failure.A dhr review was performed.There were no deviations or non-conformities identified in relation to the reported error.All tests and inspections were completed with passing results.Although a root cause could not be determined, the most likely cause is related to the patient condition at the time of initiation of ecmo support (ecpr).It is possible that anticoagulation therapy was administered but not effective in preventing clotting or that the circuit was incorrectly connected/primed.As a specific root cause was not determined, corrective actions were not identified.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

• Brand Name: TANDEMLUNG OXYGENATOR
• Common Device Name: OXYGENATOR, 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: 17500775
• Report Number: 2531527-2023-00024
• Device Sequence Number: 17730882
• Product Code: DTZ
• UDI-Device Identifier: 00814112020609
• UDI-Public: (01)00814112020609(11)230126(17)241203
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K153295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2024
• Device Model Number: 5160-0000
• Device Lot Number: 00606347
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown