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 Fluid/Blood Leak (1250)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

The inspire 8f oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa (item 044061000, lot 2214400099).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 oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone reservoir (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 italia manufactures the inspire 8f oxygenator.The incident occurred in clinton township, michigan, united stated of america.The involved device has been requested for return to sorin group italia 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 italia has received a report that when the customer connected the water lines to the inspire 8f oxygenator, the noticed water coming out of the oxygenator outlet.There was not patient involvement.

Manufacturer Narrative

Livanova received a report that, when recirculating water from the heater cooler equipment into the heat exchanger (he) module of inspire oxygenator 8f, water droplets were observed into the outlet port of blood compartment.There was no patient involvement.The complained oxygenator was investigation at sorin group italia.Visual inspection found no visible sign of damage to fiber bundle capillary of he module.Integrity of the water compartment was tested as per air leak test in the same parameters applied during the in-process performed on 100% of the units in manufacturing line.According to test results, complained unit successfully passed the leak test.Verification of the dhr confirmed the unit was released as conform according to specifications.Review of the livanova complaints database revealed no further similar cases relevant to complained oxygenator lot.Since no device malfunction could be reproduced, it cannot be ruled out that observed generation of water in the blood outlet compartment may be correlated with condensation event developed at customer site, due to the possibility of water molecules to pass through the oxygenator fibers depending on temperature difference between water side and blood side (i.E.When warm water is circulating inside the inspire heat exchanger and its temperature is markedly diverging in respect to inner plastic surfaces temperature).The observed water vapor condensation against blood side, however, does not affect performance or sterility of inspire.Once the blood side is primed, the small amount of condensed water is absorbed into the prime.Risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• 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
• 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: 15176534
• MDR Text Key: 305053686
• Report Number: 9680841-2022-00035
• Device Sequence Number: 1
• Product Code: DTZ
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• 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: 2205070002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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