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

Model Number	050715
Medical Device Problem Codes	Increase in Pressure (1491); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.10.Livanova manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in united states.Through follow-up activity, livanova learned that these drugs were given because of increased pressure drop.They are not part of standard clinical protocol.In addition, it was established that no pre-membrane and post-membrane pressure values were measured.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 italia received a report that high transmembrane pressure occurred during a procedure.Medical team elected to administer mag 2gm and albumin 12.5gm.Surgery was completed without any need for unit change-out.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova requested support of medical expert to evaluate the clinical effects of reported administration of magnesium and albumin.Medical expert confirmed that the use of albumin is part of the common practice in the priming volume in order to make it more compatible.There is no clinical evidence that albumin actually reduces the platelet activation.This is applicable to magnesium too.In conclusion, use of albumin and magnesium is not intended as a medical intervention to preclude serious injury but rather as a hospital practice without any direct impact on the coagulation.As per the above, the event has been reassessed as no longer reportable.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 6F STERILE
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola
• 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: 17442871
• Report Number: 9680841-2023-00032
• Device Sequence Number: 11395833
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)260219(10)2302200077(240)050715
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2026
• Device Model Number: 050715
• Device Lot Number: 2302200077
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2023
• 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