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

Model Number	6F PH.I.S.I.O.
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia has received a report that, during set up of the heart lung machine, the perfusionist noticed a piece of foreign matter in the inspire 6f oxygenator arterial outlet.The oxygenator was not used.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Sorin group italia manufactures the complained inspire 6f hollow fiber oxygenator with integrated arterial filter.The incident occurred in (b)(6), new zealand.The involved device has been requested for return to sorin group italia for investigation and not yet received.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not received.
Additional Manufacturer Narrative
Customer provided clear photographic evidence and the complained particle to livanova facility for investigation.Fourier-transform infrared spectroscopy (ftir) of the complained particle found a correlation of 41% with cellophane.Therefore, the most probable origin of the particle is a fabric fiber/filament from the operator's clothing.Dhr of the complained lot confirmed the device was released conforming to specification.Review of the livanova complaint database did not identify any other similar event relevant to the complained lot thus excluding any systematic issue.The most probable root cause was any isolated event occurred in manufacturing line not identified during the final visual controls before product release.As per livanova continuous improvement program, cr-mir-2021-0492 has been issued to revise inspire manufacturing procedure by providing a visual guidance to operators to correctly identify and reject visual and shape defects of inspire products (oxygenators and hvr).In this regard, a dedicated focus on dented material and presence of foreign material issues is under implementation to remark visual acceptance criteria to follow in the assembly phase.The manufacturing personnel have been involved in a dedicated training meeting.The risk is in the acceptable region.No other specific action was currently deemed necessary.Livanova will keep monitoring the market for similar events.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 6F 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: 15672528
• Report Number: 9680841-2022-00047
• Device Sequence Number: 12354538
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)241024(10)2110260076(11)211026(240)050715
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 10/24/2024
• Device Model Number: 6F PH.I.S.I.O.
• Device Catalogue Number: 050715
• Device Lot Number: 2110260076
• Was Device Available for Evaluation?: Yes
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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