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

Model Number 5160-0000

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

Patient Problems Hemolysis (1886); Thrombocytopenia (4431)

Event Type  Injury  

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.Cardiacassist inc.Manufactures the tandemlung oxygenator.The incident occurred in (b)(6).Based on the information currently available, a medical assessment was requested revealing that the reported hemolysis is not related to tandemlung oxygenator and that it is a risk associated to the procedure itself.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device in use.

Event Description

Livanova received report that during ecmo support of a covid-19 patient a dual tandemlung oxygenators setup was used and hemolysis associated with anemia requiring rbc transfusion was noticed on (b)(6) 2021.Due to significant hemolysis noted and thrombocytopenia, the flow was minimized maintaining adequate global perfusion.The patient has been off heparin infusion for roughly 24 hours and reportedly there is a plan to restart heparin infusion for or possible clots formation.

Manufacturer Narrative

Section b.1 and b.2 have been corrected and aligned to what reported in h.1 in the initial report.H.10: serial number of oxygenator was not provided and remains unknown.As stated in the initial report, as per medical assessment conducted on this event, the oxygenator is not possibly related to the reported hemolysis.Oxygenator may have contributed to clots formation.However, this is unlikely since the support was on a patient affected by covid-19 which was not subjected to anticoagulation therapy for 24 hours.Covid-19 disease can contribute/lead to clotting formation due to a higher incidence of coagulopathy and thrombosis.Covid-19 desease in combination with an inadequate anticoagulation therapy are the most likely causes of the reported clots.In conclusion, both hemolysis and clotting are not related to any oxygenator malfunction.

Event Description

See initial report.

• Brand Name: TANDEMLUNG OXYGENATORS
• 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 15238
• MDR Report Key: 12506083
• MDR Text Key: 275161075
• Report Number: 2531527-2021-00041
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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
• Date Manufacturer Received: 10/21/2021
• 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