MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03705

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

The issue occurred prior to any patient involvement.The inspire 8f m 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).The involved inspire 8f m oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone oxygenator (catalog number 050703) is also 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 oxygenator.The incident occurred in (b)(6), united states.The involved device has been requested for return to sorin group (b)(4) for investigation.The device has not yet been received in sorin group (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not yet received.

Event Description

Sorin group (b)(4) has received a report that, during set up of a circuit prior to a procedure, the perfusionist turned on the water flow to do the water leak test and found that water filled the tubing circuit and reservoir of the inspire oxygenator.The issue occurred prior to any patient involvement.

Event Description

See initial report.

Manufacturer Narrative

The dhr review of the complained lot confirmed the oxygenator was released conforming to product specification.The unit has passed the air leak tests performed during manufacturing before release.Review of the livanova complaint database did not identify any other similar event relevant to the lot of oxygenator or heat exchanger module thus excluding any systematic issue.The complained oxygenator was returned to livanova for investigation.The visual inspection found no obvious damage or crack.To verify the integrity of the blood and water compartments of the complained oxygenator, the unit was air leak tested in the same condition as during manufacturing tests.The unit passed the air leak test of both water and blood compartment thus excluding any damage to the two compartments.No device malfunction could be confirmed, the oxygenator behaved as expected.The root cause of the issue at the customer site remains unknown.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• 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: 12867866
• MDR Text Key: 283255109
• Report Number: 9680841-2021-00033
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 008036221334666
• UDI-Public: (01)008036221334666(240)044043000(17)230930(10)2126400019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 03705
• Device Lot Number: 2106250003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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