MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6 STERILE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	050713
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 6 hollow fiber oxygenator.The incident occurred in india.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Clarifications on when the issue occurred and duration of the change-out have been requested.
Event or Problem Description
Sorin group italia has received a report of a leakage from the temperature probe of any inspire 6 oxygenator.Medical team elected to change-out the oxygenator to complete the case.There is no report of any patient injury.
Additional Manufacturer Narrative
Through follow up with the customer, livanova learned the issue was detected when priming the circuit, hence prior to any patient / user involvement.Review of complaints database revealed no further case notified for batch concerned from the market.No visual evidence showing the defect was provided; however, based on available information and considering the review of similar events, it is reasonable to conclude that an internal leakage pathway through temperature sensor connection occurred at customer facility.Non-conformity activity was opened to address leakage events from the inner core of inspire temperature probe connector housing.Investigation identified as root cause the presence of voids in probe holder body due to incomplete mold filling of a specific cavity.No information about the specific probe cavity involved in this case could be retrieved.To prevent reoccurrence, a mold balancing of all the cavities has been performed.Verification of manufacturing records showed that complained unit was manufactured after action implementation.Since the issue was detected during priming, the case has been reassessed as not reportable.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 6 STERILE
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• 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: 16323464
• Report Number: 9680841-2023-00003
• Device Sequence Number: 15411113
• Product Code: DTZ
• UDI-Device Identifier: 08033178112352
• UDI-Public: (01)08033178112352(17)251017(10)2210180001(240)050713
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130209
• 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): 04/12/2023

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: 10/17/2025
• Device Model Number: 050713
• Device Lot Number: 2210180001
• Was Device Available for Evaluation?: Yes
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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