MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	6F PH.I.S.I.O.
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia has received a report that, during a mitral valve replacement surgery, while on pump, blood leak from the purge line of the inspire 6f oxygenator was observed.Medical team elected to change-out the oxygenator.There is no report of any patient injury.
Additional Manufacturer Narrative
A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not available.
Additional Manufacturer Narrative
According to follow up information received by the customer on 9 september 2022, the oxygenator change-out was completed in less than 3 minutes and no heterologous blood was administered to the patient.Based on the above information, the event has been reassessed as not reportable.
Event or Problem Description
See intial report.

• Brand Name: INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• 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: 15359897
• Report Number: 9680841-2022-00036
• Device Sequence Number: 5227503
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)250419(10)2204200002(240)050715
• 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): 10/03/2022

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 Model Number: 6F PH.I.S.I.O.
• Device Catalogue Number: 050715
• Device Lot Number: 2204200002
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2022
• 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