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

Catalog Number 03705

Device Problems Restricted Flow rate (1248); Increase in Pressure (1491)

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

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.No patient information has been provided.D.4.The inspire 8f oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack is (b)(4).G.5.The involved inspire 8f oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The stand alone oxygenator (catalog number 050703) is also registered in the usa (510(k) number: k180448).H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.H.10.Livanova manufactures the inspire 8f oxygenator.The incident occurred united states.The involved device has been requested for return for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group italia has received report that, one minute after initiating a bypass, patient blood flow dropped to 1.9 l/min.The perfusionist then increased the pump speed to 2500 rpm and the flow dropped to zero.The surgeon checked the cannula and table lines for any kinks and there were none.The perfusionist checked all their lines and there were no kinks.The arterial line was clamped and the recirc line was opened with very little flow at 2500 rpm.Medical team elected to change out the entire circuit.The procedure was completed with no issue.There is no report of any patient injury.

Manufacturer Narrative

The complained oxygenator was returned to livanova for investigation.Initial visual inspection found the oxygenator clean without any visible traces of dried blood inside fiber bundle.The device was washed and functionally test with bovine blood as per design specifications and relevant uni en iso.Laboratory test could not reproduce any restricted flow rate or increased pressure drop: oxygenator which behaved as expected.The dhr could not identify any deviations or nonconformities relevant to the issue and a complaints database analysis also revealed that no similar complaints have been submitted about this specific issue based on the above, the flow issue experienced by customer was confirmed to be not device-related.Therefore, it cannot be excluded that complained event may have been caused by a defect into circuit connected to the oxygenator.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep 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; strada statale 12 nord; mirandola (mo)
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17236598
• MDR Text Key: 318223936
• Report Number: 9680841-2023-00028
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03705
• Device Lot Number: 2209300236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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