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

Model Number 03705

Device Problem Increase in Pressure (1491)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.No patient information has been provided.D.4.The inspire 8f m oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack is (b)(4).G.5.The involved inspire 8f m oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The stand alone oxygenator (catalog number 050703) is also registered in the usa (510(k) number: k180448).H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.H.10.Sorin group italia manufactures the inspire 8f m oxygenator.The incident occurred in united states.The involved device has been requested for return to sorin group italia for investigation.Through follow up with the customer, livanova learned that the change out duration was 4 minutes.The entire system, including the heart/lung machine was changed out.At the time of change out, disposable versus mechanical failure was not able to be determined, which is the reason why all components were changed.The change out occurred approximately 30-40 minutes into the bypass run.A field service engineer verified the s5 had no issue and the heart lung machine was put back into service.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, during a procedure, the perfusionist was unable to flow with max rpm's on the revolution pump.Both arterial line and patient pressures dropped due to the inability to flow through the inspire 8f oxygenator.The medical team elected to change out the circuit and the procedure was completed with no further issue.There is no report of any patient injury.

Manufacturer Narrative

After decontamination by gamma-rays (as per livanova procedure on blood contaminated goods), returned units (oxygenator and revolution pump) were found to be clean and empty when visually inspected, with no visible traces of dried blood inside fiber bundle or body impeller/shaft.No damage to white upper bearing of revolution pump was detected.Oxygenator was functionally tested with bovine blood as per design specifications and relevant uni iso.Returned revolution pump used by customer was assembled into the circuit to convey blood to the oxygenator under testing.Laboratory test could not reproduce any increased pressure drop across the oxygenator which behaved as expected without any performance deviation identified in terms of pressure excursion in blood path.Based on investigation results and considering the review of similar events, reported failure has been traced back to temporary deposition/build-up of biological material into the oxygenator fibers as a consequence of platelet adhesion and fibrin layer deposition.Livanova conducted a literature and technical analysis about the trans-membrane oxygenator pressure gradients (cp_mir_mis_000682, rev 000).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.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: INSPIRE 8F M
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16761067
• MDR Text Key: 313504848
• Report Number: 9680841-2023-00014
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03705
• Device Lot Number: 2211100056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 07/30/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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