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

Model Number	5160-0000
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report that a tandemlife oxygenator abruptly experienced zero flow during support.Using super therapeutic anticoagulation, the user was initially able to achieve the 4.0lpm goal for patient blood flow, however this decreased to 2.5lpm within 5 minutes of support without changing the pump speed.The user attempted to troubleshoot by re-positioning the venous drainage cannula, which required a momentary pause of support.Upon re-initiating support, zero flow was able to be achieved via the circuit.A new circuit was primed and flow was initiated at appropriate flow.The replaced circuit was inspected for clotting but no thrombus was identified, though the oxygenator was unable to drain either by gravity or syringe suction.There was no patient impact reported.
Additional Manufacturer Narrative
A1.-a6.Patient information was not provided.D4.The complained tandemlung oxygenator is a subcomponent of a kit.Udi provided in this report is for the kit the oxygenator was built into.H10.Livanova manufactures the tandemlife oxygenator.The incident occurred in tacoma, washington.There was no patient impact.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.All tests and inspections were completed with passing results.A device evaluation is anticipated but has not yet begun, as the device has not yet been returned.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The complained device was returned to livanova for evaluation.Visual inspection identified one area of biological deposit visible on bottom right of device close to inlet potting.A functional inspection was also performed.The oxygenator was connected to a circuit with a stock engineering pump and sterile water to collect pressure flow data.The hq tests performed, one with a stock engineering pump and the other with the returned pump, demonstrated pressure drops across the oxygenator which were comparable to a clean, stock oxygenator.There was no evidence found to suggest clot formation or any failure of the oxygenator returned for analysis, and there was no evidence to suggest any failure of the pump used in the case.As the reported issue could not be reproduced and no functional issues were identified with the oxygenator, a specific root cause was not determined and corrective actions were not identified.Based on the results of functional testing of the pump and oxygenator, it is considered unlikely that clot formation in either of those devices was the cause of reduced flow.It is unclear from the event report whether the cannula was swapped along with the pump and oxygenator during circuit exchange, and no cannula were returned for analysis.It is possible that a thrombus or other blockage formed in the cannula leading to the reduction in circuit flow.The failure to drain or force additional fluid through the oxygenator may have been caused by a vapor lock in the device or a clot that formed after blood had been sitting in the device after its removal from the support circuit.Static priming or draining of devices with gravity or syringe pressure is substantially more difficult after introduction and stasis of fluid within the device.Any clot could have deteriorated during return shipment or flow testing and therefore did not impact the hq tests performed during investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental.

• 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: 17337986
• Report Number: 2531527-2023-00017
• Device Sequence Number: 6477766
• Product Code: DTZ
• UDI-Device Identifier: 00814112020609
• UDI-Public: (01)00814112020609(11)230327(17)250103
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/11/2023

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: 01/03/2025
• Device Model Number: 5160-0000
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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
• Patient Sex: Unknown