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

Model Number 5160-0000

Device Problem Obstruction of Flow (2423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/16/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the tandemlung oxygenator.The incident occurred in (b)(6).Based on information currently available, it is likely that low flow issues were caused by clots and fat deposits obstructing oxygenator and not device related issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova received report that during ecmo support, low flow issues occurred on (b)(6) 2021.Major bleeding was reported as pre-existing condition.Albumin and 1u rbc were given to the patient.On (b)(6) 2021 loss of flow, chattering, hypotension and hypoxemia were observed with reportedly borderline o2 saturation (88).Throughout the day patient had consistent episodes of chattering with low flows, hypoxia and hypotension.Blood clots could be noticed at the edge of the oxigenator.On (b)(6) 2021 low flow issue still present and fatty deposits were found in the oxygenator.Po2 decreased to 64 and chattering present.The tandemlung oxygenator was replaced following tandemlife representatice contacted for troubleshooting.

Event Description

See initial report.

Manufacturer Narrative

H.10: the patient had multiple issues at the same time.There is an adverse event for the bleeding, which is why the rbcs were given.The pump chatter may indicate that the patient is volume depleted.In this type of cases replacing blood products lost through bleeding will help and in this specific event albumin was given to increase the volume.As stated in the initial report, the oxygenator was noted to have clots and fatty deposits, which is the reason for the oxygenator exchange.This may have been contributing to the low flow state along with the volume depletion.The oxygenator had been in use for 7 days, so it is reasonable to expect a change-out after 7 days of use.The bleeding event is separate from the oxygenator exchange.Based on all retrieved information, the adverse event and low flow issues were not device related and most likely associated to procedural/patient conditions.

• Brand Name: TANDEMLUNG OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• MDR Report Key: 12472102
• MDR Text Key: 271529087
• Report Number: 2531527-2021-00037
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1