MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 7F

Model Number	050730
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the inspire 7f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).Analysis of pump sheet of the case showed the change-out of the oxygenator lasted about 6 minutes.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italia has received a report that, durina a procedure, increased transmembrane pressure was observed.Medical team elected to change out the oxygenator.Following the membrane replacement, pre membrane pressure remained between 250 to 310 mmhg at c.I.Of 2,3.There is no report of any patient injury.
Additional Manufacturer Narrative
Analysis of livanova complaints database revealed no other similar event notified for the batch concerned from the market.Based on the available data, and taking into account the review of similar events, reported issue was reasonably traced back to unexpected and progressive build up of biological deposits (platelet aggregates and fibrin mass) inside the oxygenator fibers which reduced the open surface for blood flow.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.No other action is deemed necessary.The risk is in the acceptable region.Livanova maintains and documents periodic customer events monitoring process to evaluate actions for products improvement.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 7F
• Common Device Name: INSPIRE 7
• Manufacturer (Section D): SORIN GROUP ITALIA; 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: 19228059
• Report Number: 9680841-2024-00013
• Device Sequence Number: 6882501
• Product Code: DTZ
• UDI-Device Identifier: 08033178113359
• UDI-Public: (01)08033178113359(17)270109(10)2401100054(240)050730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 050730
• Device Lot Number: 2401100054
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/29/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown