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

Model Number 5160-0000

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement.Lot number is unknown.It will be provided in a supplemental report if available.Cardiac assist inc.Manufactures the tundemlung oxygenator.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that during a support, after tandemheart insertion, a thrombus formation was observed in the circuit at the proximal side of the tundemlung oxygenator.The tandemheart component and the oxygenator were exchanged.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the issue was resolved during the procedure by stopping the pump for one minute and exchanging the oxygenator.The support was thus started again.Clotting is a multifactorial event that may be related to insufficient anticoagulation, extended periods of low flow and patient coagulopathies.Based on the available information, the exact cause of the thrombus formation is this case cannot be determined.If any additional information pertinent 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
• MDR Report Key: 10051759
• MDR Text Key: 190773822
• Report Number: 2531527-2020-00016
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/13/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention