MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY; HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

Model Number	6 PH.I.S.I.O.
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the inspire 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).Per exemption letter number e2016005.Nor the complained oxygenator neither any picture of the issue were made available for event investigation.Based on similar events previously investigated, the leak could have been caused by either a delamination or a crack of the metal pin of the holder of the temperature probe.Without the possibility to investigate the unit, a clear root cause could not be assessed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As a part of continous improvement process, a new supplier and temperature probe manufacturing process has been validated in september 2018.The complained oxygenator was manufactured before september 2018.Livanova will keep monitoring the market for similar events.Device not available.
Event or Problem Description
Sorin group (b)(4) has received a report that at the beginning of the cardiopulmonary bypass, a leak noticed from the arterial temperature probe well of the inspire 6 oxygenator according to information, no leak was detected during priming.Total blood loss was approximately 20cc.Livanova was informed by us mail on 12/31/2018 the case was reported: report medwatch # (b)(4).

• Brand Name: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
• Common Device Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 8284773
• Report Number: 9680841-2019-00003
• Device Sequence Number: 1599031
• Product Code: DTZ
• UDI-Device Identifier: 08033178112352
• UDI-Public: (01)08033178112352(17)210516(10)1805170248
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/31/2018

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: Other
• Device Expiration Date: 05/16/2021
• Device Model Number: 6 PH.I.S.I.O.
• Device Catalogue Number: 050713
• Device Lot Number: 1805170248
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2019
• Device Age: 6 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR