MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL OXYGENATOR, CARDIOPULMONARY BYPASS; INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER AND PHISIO H

Model Number	8F PH.I.S.I.O.
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue occurred prior to patient involvement.Sorin group (b)(4) manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).The involved device has been received at sorin (b)(4) on (b)(6) 2019.Investigation is on-going.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 (b)(4) has received a report that, during set-up, a foreign material was seen by the cardioplegia arterial outlet of the inspire 8f.The device was changed-out.The issue occurred prior to patient involvement.
Additional Manufacturer Narrative
The complained issue was the presence of extraneous material by the cardioplegia port inside the inspire oxygenator.The issue was identified at the packaging setup prior to any patient involvement.The complained oxygenator was returned livanova for investigation.Detailed visual inspection of the returned oxygenator, especially close to the cardioplegia port, could not identify any extraneous particle inside the oxygenator.Dhr of the batch did not highlight any issue possibly related to the claimed defect.Traceability of the batch shows that this is the unique part of a batch that has been complained for this issue.Therefore, it can be considered an isolated event.Accordingly, similar complaints showed no trend.It shall be noted that the complained oxygenator was returned with all connectors opened.It could not be excluded that the claimed extraneous material was movable and that it has moved outside the oxygenator during the returning to livanova for investigation.The likelihood of occurrence of the complained failure for the considered period is in line with what documented and accepted in the inspire risk management file according to livanova investigation, no issue could not be confirmed and no root cause could be assessed.As the occurrence of such kind of event is low and a clear root cause could not be assessed, no corrective action will be undertaken.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Common Device Name: INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER AND PHISIO H
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9510704
• Report Number: 9680841-2019-00047
• Device Sequence Number: 2650976
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)220721(10)1907220107
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130433
• 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): 11/26/2019

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: 07/21/2022
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 1907220107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1