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  malfunction  

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 available.H.10.Livanova manufactures the inspire 8m hollow fiber oxygenator.The incident occurred in (b)(6), 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.

Manufacturer Narrative

Multiple follow-up attempts were conducted to retrieve further details about type of drugs administered.However, no additional information is available for this event.Based on medical opinion, it was revealed that there is no pressure excursion or other which requires drugs and heparin administration.Therefore, the event is being reassessed as not a medical intervention to preclude serious injury.However, since the change out of the oxygenator was never confirmed or excluded, the event remains reportable and it is re-assessed as a malfunction.It is very likely that the reported event was caused by progressive build-up of biological aggregates and platelet adhesion in the oxygenator which gradually reduced the open surface for blood flow.Livanova conducted a literature and technical analysis about the trans-membrane oxygenator pressure gradients.Pressure drop excursion across the oxygenator is a known phenomenon reported in literature in all membrane oxygenators.The main cause of the pressure excursion has been identified in the platelet activation and adhesion within the oxygenator that progresses to increase resistance to blood flow during cardiopulmonary bypass.The factors influencing pressure excursions can be assigned to three main areas: - surgery clinical impact - cpb clinical impact - pathological patient conditions research on the phenomenon consistently concludes that the pressure excursion is complex and multifactorial and in most of the cases none of the factors considered singularly causes the phenomenon.An accurate analysis and monitoring of the factors identified can lead to the reduction of the phenomenon during cpb.Nevertheless at current state of knowledge the complex nature of the phenomenon does not allow its complete elimination.

Event Description

See initial report.

• Brand Name: INSPIRE 8F M
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18442015
• MDR Text Key: 331860169
• Report Number: 9680841-2024-00002
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention