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

Model Number	050715
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia received a report that, after entering into bypass, a blood leak was observed form the temperature probe holder of the inspire 6f oxygenator.Medical team elected to change out the oxygenator.There is no report of any patient injury.
Additional Manufacturer Narrative
H.10.Livanova manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in india.The involved device is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Analysis of livanova complaints database revealed no other similar event notified for batch concerned from the market.Explanatory pictures as evidence of the leakage pathway were made available, highlighting that blood poured out of the inside of temperature probe connection holder.No product return was therefore arranged.Investigation identified the root cause of the leak is a partial lack of adhesion between the inner metal pin and the co-molded abs polymer (t-probe components), particularly, majority of the leaking units assembles a specific cavity of probe holder.No information about cavity sub-assembled in complained unit could be retrieved in this regard.As containment action, sorting of affected cavity in manufacturing line to venous temperature probe site of inspire (hvr inlet port) subjected to low operating pressure conditions has already been implemented.Further investigation is currently in progress to define the best solutions to correct the fault and prevent recurrences.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: INSPIRE 6F STERILE
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17077048
• Report Number: 9680841-2023-00020
• Device Sequence Number: 14015729
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)260208(10)2302090157(240)050715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/25/2023

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: 02/08/2026
• Device Model Number: 050715
• Device Lot Number: 2302090157
• Was Device Available for Evaluation?: No
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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