MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHEL; HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

Model Number	8F PH.I.S.I.O.
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	02/01/2019
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.Per exemption number e2016005.The involved device has been requested for return to sorin group (b)(4) for investigation.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 a procedure, a sudden drop of blood flow was observed.The medical team elected to change-out the oxygenator.On (b)(6) 2019, livanova was informed that after a few days of induced coma, patient presented light neurological injury and that the change-out lasted nearly 5 minutes.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).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).The involved device has been returned to the manufacturer and submitted to gamma ray decontamination prior the inspection.The visual inspection found no defects nor non-conformities.No specific corrective action has been identified at the present date.Livanova will keep monitoring the market for similar events.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 8F: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHEL
• Common Device Name: HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8424330
• Report Number: 9680841-2019-00011
• Device Sequence Number: 2171092
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)211115(10)1811160004
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 05/28/2019

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: 11/15/2021
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 1811160004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2019
• Device Age: 4 MO
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR