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

Catalog Number 050714

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 12/06/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 339138381
• Report Number: 9680841-2024-00009
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)260721(10)2307220002(11)230722(240)050714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2023
• 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