MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL OXYGENATOR, CARDIOPULMONARY BYPASS; INSPIRE 6 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL SINGLE CHAMBER RE

Catalog Number 03706

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information has been provided.The inspire 6 phisio oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The lot of the sterile convenience pack is unknown.The expiration date and the unique identifier (udi) are unknown.The involved inspire 6 phisio oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone oxygenator (catalog number 050700) is also registered in the usa (510(k) number: k180448).The lot of the sterile convenience pack is unknown.The device manufacture date refers is unknown.Sorin group (b)(4) manufactures the inspire 6 phisio oxygenator.The incident occurred in (b)(6) (united states).The involved device has been requested for return to sorin group (b)(4) for investigation but not yet received.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.

Event Description

Sorin group (b)(4) has received a report that, 30 minutes after the bypass was begun, a leak near the temperature port of the inspire 6 oxygenator was identified.The medical team elected to change out the oxygenator.The change out took 5 minutes.The procedure was completed with no issue.There is not report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10 sorin group italia manufactures the inspire 6 phisio oxygenator.The incident occurred in newport news, virginia (united states).The complained oxygenator was returned to livanova for investigation.Leak test confirmed the leak between the polycarbonate holder of the temperature probe and its metallic pin.Dhr verification did not reveal any relevant information possibly linked with the claimed defect.Based on complaints review, the reported issue is not related to a specific lot nor oxygenator model related.Livanova investigation suggested the most probable root cause of the claimed leak is a delamination between the metal pin and the co-molded polycarbonate holder.Such a partial detachment caused a leakage path through the metal-plastic interface.According to investigation, this leak is not detectable during the in-process leak tests performed on 100% of inspire oxygenator units during manufacturing.The leak is triggered and enhanced by subsequent stresses such as sterilization and shipping stresses.The frequency of this type of event is low (remote).To further reduce the occurrence of this type of event, as part of continuous improvement project, n additional in-line leak testing of the temperature probe has been validated and implemented during the co-molding process at supplier site on december 2019.The unit involved in the present complaint was manufactured before the implementation of the above described improving action.Livanova will keep monitoring the market.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: INSPIRE 6 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL SINGLE CHAMBER RE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9437883
• MDR Text Key: 208577018
• Report Number: 9680841-2019-00041
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03706
• Device Lot Number: 1906040008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1