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

Model Number 5160-0000

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2023

Event Type  Death  

Manufacturer Narrative

D4.The device serial/lot number was not provided, so expiration date and udi number could not be determined.H4.As the serial/lot number was not provided, manufacture date could not be determined.H.10 livanova manufactures the tandemlung oxygenator.The incident occurred in (b)(6).While the patient did die, the reported death was related to patient condition prior to going on support with the device and has not been linked to usage of the tandemlung oxygenator.The device was discarded by the user therefore was unavailable for return to livanova.A dhr could not be performed, as no serial number was provided.As an evaluation of the device could not be conducted, a root cause could not be determined.However, through follow-up communication with the livanova sales representative and medical affairs, it was determined that there was no known malfunction of the oxygenator.The reported event involves a subjective assessment of o2 transfer based on blood color.The user did not measure or record any pre- or post-oxy gas, so it is unknown if any performance issue occurred.In addition, the reported flow rate of less than 3lpm is a likely source of therapy limitation.The patient also was reportedly without a pulse and receiving cpr for close to an hour prior to the tandemlung circuit being hooked up.Once hooked up, the device was only used for 10-15 minutes before ending support.Given that the patient condition was very poor prior to hooking up, the color change is a subjective assessment, and the reported flow rate was only 2.4lpm, it could not be concluded that there was any malfunction of the oxygenator.A flow rate of 3lmp may not properly assist with oxygen delivery, address oxygen debt or adequately support cardiopulmonary collapse.The reported issue may have been the result of too low of a flow rate.As a malfunction was not confirmed and no specific root cause was identified, no corrective actions have been determined for this event.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : device not available for return.

Event Description

Livanova received a report that a tandemlung oxygenator did not perform according to expectations during a procedure.After the circuit was connected to the patient at 6200 rpm and 2.4lpf, the perfusionist noted the blood exiting the oxygenator was not immediately changing color.The report indicated that the patient had been receiving cpr for almost an hour with little to no pulse prior to being hooked up to the oxygenator.Troubleshooting was performed by changing out the oxygen tank and the o2 line but the user was still not pleased with the color change.After 10-15 minutes of the patient being on support with the oxygenator and no vitals returning, the decision was made by the family to stop support.While the patient did die, this was a function of patient condition and in no way related to the oxygenator performance, which did not have a known malfunction.

• Brand Name: TANDEMLUNG OXYGENATOR
• Type of Device: 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: 17274762
• MDR Text Key: 318550791
• Report Number: 2531527-2023-00016
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5160-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other; Death
• Patient Age: 60 YR
• Patient Sex: Male