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

Model Number 5160-0000

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Thrombosis/Thrombus (4440)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Cardiacassist 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.Clinical study-device not available.

Event Description

Livanova received a report that during patient support with a tandemlung oxygenator, on (b)(6) 2021 red cell lysis was observed as well as a decrease in po2 to 110.Reportedly clots were also noticed from (b)(6).It was decided to replace the oxygenator.

Event Description

See initial report.

Manufacturer Narrative

H10: dhr review has not pointed out any deviations or non-conformities possibly relevant to occurred issue.Through follow up communication livanova learned that principal investigator (dr.Roan) reported that there was no hemolysis adverse event and that the oxygenator was changed out only due to decreasing po2 (110).Thus, codes in h.6 section have been updated accordingly and the type of report in h.1 section has been changed.In addition, it was learned that the patient was affected by covid-19 and the oxygenator change out occurred after 11 days of support.Covid-19 disease can contribute/lead to clotting formation due to a higher incidence of coagulopathy and thrombosis.Based on the available information, the oxygenator did not malfunction and that thrombus formation due to covid-19 patient conditions reduced the gas exchange at the level of the device and consequently the po2 decreased.In conclusion, no hemolysis had occurred and the event is only about device change-out due to po2 =110 which is not likely to result in serious injury.Oxygenator change-out is expected and planned during prolonged patient support and conducted by trained personnel as foreseen by device instruction for use.Therefore, an oxygenator change-out is not likely to result in serious injury and the reportability decision has been re-evaluated to not reportable event.

• 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 80004
• MDR Report Key: 12632664
• MDR Text Key: 276403346
• Report Number: 2531527-2021-00043
• 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: 10/14/2021

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?: 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
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 11/12/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other