MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL. INSPIRE 7 M; INSPIRE OXYGENATORS

Catalog Number	050725
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.D.4.Lot number is unknown.This information will be provided in a supplemental report if made available.H.4.As the lot number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.H10: sorin group italy manufactures the inspire 7 m oxygenator.The incident occurred in münchen, germany.The oxygenator was disposed of after the change.Perfusion was ended with a different oxygenator.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italy has received a report of light gradual increase in trans-membrane pressure across the inspire and decreased co2 removal.Medical team elected to change out the oxygenator.There is no patient injury.
Additional Manufacturer Narrative
H11: through follow-up communication livanova learned lot number of the involved oxygenator (information has been added to the dedicated d.4 section).In addition it was learned that oxygenator change out lasted less than 3 minutes, therefore event has been re-assessed as not reportable.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 7 M
• Common Device Name: INSPIRE OXYGENATORS
• 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: 19284348
• Report Number: 9680841-2024-00015
• Device Sequence Number: 7640261
• Product Code: DTZ
• UDI-Device Identifier: 08033178113182
• UDI-Public: (01)08033178113182(17)260213(10)2302140141(240)050725
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201916
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2026
• Device Catalogue Number: 050725
• Device Lot Number: 2302140141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2023
• 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