MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR; INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

Catalog Number 050702J

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The expiration date refers to the sterile finished product.The complained inspire 6f m oxygenator (catalog number 050702j, lot 1803120219) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050702j is similar to the inspire 6f oxygenator 050702, which is distributed in the usa, for which the device identifier is 08033178112277.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).The product item 050702j is not distributed in the usa, but it is similar to the inspire 6f m oxygenator 050702, which is distributed in the usa (510(k) number: k130209).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).(b)(4).The involved oxygenator was not made available for return 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 a extraneous material was identified inside the integrated arterial filter of inspire 6f m during packaging inspection perfomed by the assembler (b)(4).The event occurred prior to any patient involvement.

Event Description

See initial report.

Manufacturer Narrative

Sorin group italia manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6), japan.Inspection of the picture provided by the customer confirmed the presence of a white extraneous material in the integrated arterial filter of the oxygenator.The complained device was not made available for investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The presence of the extraneous material is ascribable to a human error during the manufacturing and during the subsequent visual inspection steps that should have identified the extraneous material and discarded the unit.To prevent reoccurrence, the manufacturing operators will be retrained.The frequency of this type of event is low.Livanova will keep monitoring the market for similar events.H3 other text : device not available.

• Brand Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
• Type of Device: INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8598526
• MDR Text Key: 161735666
• Report Number: 9680841-2019-00019
• 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: other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: 050702J
• Device Lot Number: 1803120219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 14 MO
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1