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

Model Number 5160-0000

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

Cardiac assist inc.Manufactures the tandemlung oxygenator.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that during support with a tandemlung oxygenator an acute desaturation with abg po2 40 and post oxygenator po2 50 was noticed and oxygenator had to be exchanged immediately.Oxygenation improved after device replacement.The oxygenator was disposed of by provider.T he patient remains stable in the icu.

Event Description

See initial report.

Manufacturer Narrative

H.10: oxygenator was not available for return since it was disposed off.No serial number was provided thus dhr review could not be performed.Additional information regarding coagulation therapy and act during support were requested.No additional information has been provided by customer.The decrease in oxygen perfomance may have been due to accumulation of biological deposits within the oxygenator leading to a reduction of flow through the device and consequently to a decrease in gas exchange.However, this could not be confirmed and information currently available is not sufficient to determine the root cause of the event.Based on the current level of information, it cannot be ruled out that the reported issue is not device related and is associated to patient conditions.

• 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: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 13235253
• MDR Text Key: 283661092
• Report Number: 2531527-2022-00004
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5160-0000
• Device Catalogue Number: 5160-0000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention