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

Model Number	INSPIRE 8F M N/S
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sorin group italia received a report of inspire 8f oxygenator performance problems, upon initiation of by-pass.In details, values of partial pressure of oxygen (po2) was 47 mmhg with fi02 of 100% and gas sweep of 2.5l/min.A second oxygenator was placed in tandem with the involved one without the need to remove the patient from by-pass.Anesthetist supported the patient with additional fi02 and ventilation support.After the second oxygenator was placed, patient p02 was measured and it was 583 mmhg.There was no patient injury.Based on medical assessment, the use of two oxygenators in tandem has been considered an additional intervention to preclude serious injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.D.4.The inspire 8f m hollow fiber 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 hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone oxygenator (catalogue number 050703) is also registered in the usa (510(k) number: k180448).H.4.The device manufacturing date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.H11: through follow-up communications, livanova learned that several arterial blood gas measurements were recorded during usage of involved oxygenator: first measurement showing a po2 of 44mmhg at 80% fio2 and a sweep of 2.5; second measurement showing a po2 of 44mmhg at 100% fio2; third measurement showing a po2 of 54mmhg when the gas line was connected to an o2 tank.After the addition of the second oxygenator in tandem, po2 level reached 583mmhg; during this period, the patient was maintained at a blood flow index between 2.1 and 2.4, with no high arterial line pressure observed.The new oxygenator was connected to the o2 tank for the procedure while the original defective oxygenator was kept in line to supply isoflurane to the patient, with anesthetist continuously monitoring isoflurane levels.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: INSPIRE OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 25481877
• Report Number: 9680841-2026-900021
• Device Sequence Number: 13342879
• Product Code: DTZ
• UDI-Device Identifier: 00803622150098
• UDI-Public: (01)00803622150098(17)280213(11)260213(240)044027002(10)2604400014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INSPIRE 8F M N/S
• Device Catalogue Number: 03705 (INTO 044027002)
• Device Lot Number: 2601170005 (INTO 2604400014)
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 02/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown