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 Insufficient Heating (1287)

Patient Problem Transient Ischemic Attack (2109)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The inspire 8f m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in00185 fr bordeaux phisio lot 2003040130) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The complained inspire 8f m hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The standalone oxygenator (catalog number 050703) is 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 hollow fiber oxygenator.The incident occurred in (b)(6).The complained oxygenator has been requested for investigation and not yet returned.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 obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that during an emergency aortic dissection surgical intervention, the desired patient blood temperature could not be achieved: the temperature decrease of 3 degrees in 45 min.The temperature requested was 20°c and the temperature measured on the inspire oxygenator was 31°c.The medical team elected to not change cec circuit during the procedure and to connect a second thermal group on the same cec.The deep hypothermia (26°c) was achieved.The phenomenon is observed again during patient re-warming: the medical team elected to use of a third thermal group.According to customer information, the delay of the hypothermia was of 1 hour and 30 minutes.Unfavorable evolution of signs of digestive ischemia observed intraoperatively requiring revisions surgical.No wake-up call within 48 hours of stopping sedations.Performed on (b)(6) 2020, of a cerebral ct finding a lesion compatible with recent ischemic injury.

Manufacturer Narrative

Complained inspire 8f oxygenator was returned to livanova for investigation and subjected to gamma-ray decontamination as per livanova procedure on blood contaminated goods.Visual inspection of the returned oxygenator found blood clots inside the integrated arterial filter and in the oxygenator fiber bundle.Extensive rinsing could not completely remove the dried blood from the oxygenator.To investigate the reported failure (slow thermal exchange), the thermal exchange performance test was run in simulated use test filling circuit with saline solution.The aim of the test was to calculate the time required to reach the desired temperature value inside the unit (37°c) starting from time zero (no flow condition).Test results highlighted that the total duration of the warming step was approximately 13 minutes which is in line with expected ramping temperature profile: no warming delay could be reproduced.No other similar complaints was received.Based on investigation results, no device related failure could be confirmed and therefore no root cause could be clearly assessed.It cannot be excluded that the event was correlated with blood patient conditions and or clinical practice.Livanova will maintain 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, modena
• MDR Report Key: 10520635
• MDR Text Key: 206523936
• Report Number: 9680841-2020-00015
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Catalogue Number: 03705
• Device Lot Number: 2003040001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR