MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03705

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2019

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 (lot 1904150204) 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 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 standalone oxygenator (catalog number 050703) is registered in the usa (510(k) number: k180448).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group (b)(4) manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, during priming, a piece of plastic was identified in the housing of the inspire oxygenator.The unit was change out the issue occurred prior to any patient involvement.

Event Description

See initial report.

Manufacturer Narrative

The complained oxygenator was returned to mirandola facilities.Visual inspection of the oxygenator reveled that the device was emptied of the priming liquid before being returned.Accurate visual inspection could not identify any foreign material inside the returned oxygenator.To identify if the claimed foreign material was still present inside the oxygenator, the device was filled with water, gently stirred and emptied while filtering the exiting water to trap possible foreign material.Again, no foreign material could be identified.Dhr verification did not reveal any relevant information possibly related to the claimed defect: the device was released conforming to product specification.The complained lot of oxygenator was not involved in any other similar event.At the submission of the case, the customer has provided a video in which showed a whitish particle visible in the oxygenator filter.The particle was more likely a plastic debris originated during the manufacturing process however no conclusion could be reached as the debris was not found in the returned sample.Livanova believes the issue experienced by the customer is more likely a plastic debris originated during the manufacturing process and not identified by manufacturing personal during visual inspection of device.However, as the complained particle was not retrieved, the nature of the material could not be investigated.To avoid re-occurrence, the manufacturing personal will be retrained and sensitized on the importance of visual inspection.Livanova will maintain monitoring the market.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9222814
• MDR Text Key: 180034817
• Report Number: 9680841-2019-00037
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Catalogue Number: 03705
• Device Lot Number: 1904080222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1