MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL. INSPIRE 8 HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	050714
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10.Sorin group italy manufactures the inspire 8 hollow fiber oxygenator.The incident occurred in (b)(6).No pump sheet was provided and therefore no time evidence from case record could be retrieved.The unit was returned to livanova facility for investigation.Involved device was found clogged when visually inspected, with extended areas overcharged by dried blood.Biological deposits were also detected across the purge/cardioplegia ports.A cleaning treatment was then conducted to remove observed residues and restore pre-clinical conditions of the unit.However, blood clots could not be fully washed out of the unit.In detail, during the cleaning phase with water, a restricted flow rate through the inlet port of the unit was reproduced, thus preventing any further functional test.Review of livanova complaints database identified no other similar events notified for batch concerned from the market.Based on the information available and considering the reported time to failure (after prolonged surgical time), it is reasonable to conclude that an unexpected build-up of biological aggregates and blood clots developed inside the unit and reduced the open surface for blood flow, probably due to a temporary decrease in the anticoagulation levels.No specific device-related malfunction was established.
Event or Problem Description
Sorin group italy received a report of a sudden blood activation inside inspire 8 oxygenator during bypass on a long case.Medical team elected to change out the affected unit.No further details about surgical phase (beating heart surgery or aortic cross-clamp) and duration of the change out operation were communicated.There was no patient injury.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL.; strada statale 12 nord 86; mirandola 41037 ; IT 41037
• 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: 18957694
• Report Number: 9680841-2024-00009
• Device Sequence Number: 4591616
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)260721(10)2307220002(11)230722(240)050714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130433
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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 Expiration Date: 07/21/2026
• Device Catalogue Number: 050714
• Device Lot Number: 2307220002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown