MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RE; HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

Catalog Number 03507

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

The issue occurred prior to any patient involvement.The inspire 8f m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in00508, lot 1805290084) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The age of the device was calculated as the time elapsed between device sterilization and the date of event.(b)(4).Pma/510 (k):the complained inspire 8f m hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050703) is registered in the usa (510(k) number: k130433).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.(b)(4).The involved device has been returned to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, during circuit set up, particulate was detected by the blood outlet connector of the integrated arterial filter of an inspire 8f oxygenator.The issue occurred prior to any patient involvement.

Manufacturer Narrative

Sorin group italia manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in salamanca, spain.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).Microscopic inspection of the returned oxygenator module confirmed the presence of a drop of dried uv resin by the arterial filter.According to livanova sop, uv resin is used during the manufacturing of lid of the arterial filter.Simulated use test of the device confirmed that, in standards conditions, the dried drop do not detach from the arterial filter surface.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The presence of the drop of dried uv resin is ascribable to a human error during the manufacturing and during the subsequent visual inspection steps that should have identified the drop and discarded the unit.To prevent reoccurrence, the manufacturing floor will be retrained.The frequency of this type of event is low.Livanova will keep monitoring the market for similar events.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RE
• Type of Device: HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8453401
• MDR Text Key: 139968098
• Report Number: 9680841-2019-00015
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• 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: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 03507
• Device Lot Number: 1805240007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Device Age: 10 MO
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1