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

Model Number 5160-0000

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc.Manufactures the tandemlung oxygenator.The incident occurred in (b)(6).A review of the dhr for tandemlung did not identify any deviations or non-conformities relevant to the reported issue.Through follow-up communication livanova learned that no cracks/fractures were noted on the oxygenator.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 a tandemlung oxygenator was not working as soon as the support was started.There was a little gas exchange and the po2 decreased from 55 to 50.The circuit was exchanged.There was no report of patient injury.

Manufacturer Narrative

A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The unit was requested back to the manufacturer site for investigation.The device was tested for pressure drop and results revealed no deviation and revealed that the device was performing according to manufacturer specifications.A gas leak test was conducted the end cap of the oxygenator became separated at the bond joint.Based on the current level of information, the exact root cause of the event could not be established.However, based on the fact that gas leak test are conducted at 100% during manufacturing, it cannot be excluded that a transportation issue may have compromised the oxygenator integrity.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: TANDEMLUNG OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh 15238
• MDR Report Key: 11054105
• MDR Text Key: 265605990
• Report Number: 2531527-2020-00036
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K153295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5160-0000
• Device Catalogue Number: 5160-0000
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1