MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL. INSPIRE 6 STERILE; INSPIRE OXYGENATORS

Catalog Number 050713CN

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.D.4.The expiration date refers to the sterile finished product.The complained inspire 6 oxygenator (catalog number 050713cn) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050713cn is similar to the inspire 6 oxygenator 050713, which is distributed in the usa, for which the device identifier is (b)(4).G.5.The product item 050713cn is not distributed in the usa, but it is similar to the inspire 6 oxygenator 050713, which is distributed in the usa (510(k) number: k130209).H.4.The device manufacture date refers to manufacture date of the sterile, finished oxygenator.H.10.Sorin group italia manufactures the inspire 6 oxygenator.The incident occurred in beijing, china.Review of livanova complaints database revealed no other analogue cases notified for batch concerned from the market.Involved oxygenator is a stand-alone device delivered to customers without any venous and arterial lines pre-connected (installation is charged to customer).Part was not returned for testing nor visual evidence of the issue was provided.As per data currently available, and based on investigation results of a previous similar complaints database analysis, a mechanical damage to the outlet port of the oxygenator was excluded as cause of the event since it would have determined a leakage during priming phase which was successfully completed indeed.Therefore, it cannot be ruled out that a weakening of the arterial line connection assembled on the oxygenator port by customer over time during procedure may have led to the reported failure.The blood flow rate higher than priming flow rate together with loose or absent tie wraps securing this connection were also identified as potential contributing factors.H3 other text : part was not returned for testing nor visual evidence of the issue was provided.

Event Description

Sorin group italia has received a report that blood leakage from inspire oxygenator was found during the procedure.Through follow-up communication, livanova learned that blood poured out of arterial outlet connector.The event occurred during aortic cross clamp application.Medical team elected to replace leaking device with a new one and the change out of the oxygenator was performed in about ten (10) minutes.No negative consequences to the patient were communicated.Part is not available for return nor visual evidence of the issue was taken by customer.

• Brand Name: INSPIRE 6 STERILE
• Type of Device: INSPIRE OXYGENATORS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL.; strada statale 12 nord 86; mirandola 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18622092
• MDR Text Key: 335409321
• Report Number: 9680841-2024-00004
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050713CN
• Device Lot Number: 2305180120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1