MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL; HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR

Model Number	6F PH.I.S.I.O.
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue occurred prior to any patient involvement.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group italia manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).Per exemption number e2016005.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group italia for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Sorin group italia has received a report that, during device set-up, a black foreign particle was identified by the outlet side of inspire 6f integrated arterial filter.The issue was identified prior to any patient involvement.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in rome, italy.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).Visual inspection of the returned oxygenator module confirmed the presence of an extraneous black material by the integrated arterial filter.A review of the dhr did not identify any deviation nor non-conformity relevant to the reported issue.Livanova believes the presence of the black piece is ascribable to a human error during the manufacturing and during the subsequent visual inspection steps that should have identified the extraneous black material and discard the unit.To prevent reoccurrence, the manufacturing floor will be retrained.The frequency of this type of event is remote (0.01% < p1 = 0.1%).Livanova will keep monitoring the market for similar events.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
• Common Device Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8440408
• Report Number: 9680841-2019-00013
• Device Sequence Number: 344193
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)210114(10)1901150003
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/10/2019

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: 01/14/2021
• Device Model Number: 6F PH.I.S.I.O.
• Device Catalogue Number: 050715
• Device Lot Number: 1901150003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2019
• Device Age: 2 MO
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1