MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND TANDEMLUNG OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 5160-0000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiac assist inc.Manufactures the tandemlung oxygenator.The incident occurred in united states.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 (b)(4) received a report that a (b)(6) year old male patient was placed on support on (b)(6) 2020 with the tandemheart pump, tandemheart transseptal cannula, tandemlung oxygenator, and another manufacturer¿s venous cannula.The tandemlung oxygenator was changed-out due to worsening post-oxygenator saturations.Reportedly, there was no clot or hemolysis documented.The tandemheart device was weaned and removed on (b)(6) 2020 without further need for support.The subject was discharged from the hospital on (b)(6) 2020 to an extended care facility.

Manufacturer Narrative

H.10: based on the available information, the oxygenator worked according to the specification for 8 days.It cannot be ruled out that the prolonged use of the oxygenator with the contribution of the pre-existing patient condition may have led to the reported issue.

Event Description

See initial report.

• Brand Name: TANDEMLUNG OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10683998
• MDR Text Key: 212519601
• Report Number: 2531527-2020-00033
• 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: study
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 5160-0000
• Device Catalogue Number: 5160-0000
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1