MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND INSPIRE 8 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050714

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: sorin group italy manufactures the inspire 8 oxygenator.The incident occurred in boston, massachussets.The involved device has been requested for return to sorin group italy for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group italy received a report related to a possible blood to water leak of an inspire 8 oxygenator.The issue occurred toward the end of the procedure, when it was noticed light pink/red tinge in the water lines.Medical team chose to finish the surgery as it was very light tinged in color and the case was almost complete.There was no patient injury.

• Brand Name: INSPIRE 8 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 19070311
• MDR Text Key: 339703066
• Report Number: 9680841-2024-00010
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)261016(10)2310170004(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: 04/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 050714
• Device Lot Number: 2310170004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2023
• 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