MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F M; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 050716

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

A.1.-a.5.No patient information has been provided.G.5.The device 050716 is not registered in usa and it is similar to oxygenator (catalog number 050703) which is also registered in the usa (510(k) number: k180448).H.4.The lot of the device is pending.Therefore also the manufacture date is pending.Information will be provided when avaialable.H.10.Livanova manufactures the inspire 8m hollow fiber oxygenator.The incident occurred in siena, italy.Livanova is requesting confirmation the oxygenator was changed out during the procedure.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

Sorin group italia has received a report that, when the extracorporeal circulation started, high transmembrane pressures (237 mmhg and above) was detected at the inlet of the inspire 8f oxygenator.Drugs were infused and the problem was not resolved.Blood clot was visible in the integrated filter of the oxygenator.There is no report of any patient injury.

• Brand Name: INSPIRE 8F M
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 18442097
• MDR Text Key: 331860013
• Report Number: 1718850-2024-01001
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 050716
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2023
• Date Report to Manufacturer: 12/06/2023
• Date Manufacturer Received: 12/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention