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

Model Number 5160-0000

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

Livanova received a report that a tandemlung oxygenator stopped performing while in use on a patient being transported from one facility to another.There was no report of patient injury.

Manufacturer Narrative

D4.Device serial number was not provided, so udi and expiration date could not be determined.H4.Device serial number was not provided, so manufacture date is unknown.H10.Livanova manufactures the tandemlung oxygenator.The reported event occurred in cincinnati, oh.There was no report of patient injury.At this time, the exact nature of the event and any alleged device failure is unknown.During follow-up communication, it was reported that there was no issue with the flow through the oxygenator and the oxygenator in question had only been in use for about 4 hours when a rapid decline in performance was experienced over the 10 minute transport period.It was indicated that the patient lost oxygenation and troubleshooting revealed no issues with the air source or kinks in the gas lines, leading medical staff to believe there was an internal issue with the oxygenator.The hospital switched to a new circuit upon patient arrival to address the issue.No clots were noted in the complained oxygenator and the device was discarded following the event.Based on the information provided, it is unclear if the event was a device issue or related to the patient condition.The medical team believes it was a combination of both, but no further information could be provided and the exact nature of the malfunction is unknown.As the device was discarded, no further investigation on the complained device could be performed.A review of prior complaints found that this type of issue is typically associated with clotting and long-term use of the device.Over time, clots can develop in the circuit and oxygenator performance can slowly decrease due to thrombus as the device is used for longer and longer periods.However, the reported event described a rapid decline after 4 hours of use and no clots were identified in the circuit.As such, a specific root cause could not be determined and corrective actions were not identified.As the device serial number was not provided, a dhr review could not be performed.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

• 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: 18399837
• MDR Text Key: 331508684
• Report Number: 2531527-2023-00043
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/27/2023
• 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