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.

Device Problem Pressure Problem (3012)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).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 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.

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 Description

See initial report.

• Brand Name: INSPIRE 8F: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHEL
• Type of Device: HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8424330
• MDR Text Key: 142624595
• Report Number: 9680841-2019-00011
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)211115(10)1811160004
• Combination Product (y/n): N
• PMA/PMN Number: K130433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR