MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL OXYGENATOR, CARDIOPULMONARY BYPASS; INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

Catalog Number 03704

Device Problem Obstruction of Flow (2423)

Patient Problem Death (1802)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided.Patient birthdate was not provided.Patient information were not provided.The inspire 6f m hollow fiber oxygenator with integrated arterial filter 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 6f m hollow fiber oxygenator with integrated arterial filter is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone oxygenator (catalog number 050702) 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.Livanova usa inc manufactures the inspire 6f m hollow fiber oxygenator with integrated arterial filter.The incident occurred in (b)(6), united states.The involved device has been requested for return to sorin group italia for investigation.The involved device has been received in livanova usa inc on 27 january 2020 and it is under investigation.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 received, it will be provided in a supplemental report.Not yet decontaminated.

Event Description

Livanova usa inc has received a report that, during cardiopulmonary bypass procedure, the medical team could not reestablish blood flow forward through the arterial line through the inspire oxygenator.The medical team elected to changed out the oxygenator and revolution and then resumed the procedure.Later in the case, the medical team elected also to change out the inspire reservoir.The cardiac team was not able to re-start the heart.In the end, the patient died.

Manufacturer Narrative

H.10: the involved inspire 6f m oxygenator was returned to livanova facility for investigation.The oxygenator was returned still assembled with inspire hvr and a revolution pump.Visual inspection found presence of clotted blood in all returned devices.However, most of the clots were in the integrated arterial filter of the oxygenator, in the cardiotomy filtering section and venous inlet filter of inspire hvr.Due to the presence of massive clotting, no functional test with bovine blood could be performed because any cleaning of the device will impact the test results.The dhr review of the oxygenator did not highlight any issue possibly related to the claimed problem: the device was manufactured and released conforming to specifications.No further complaints was received for noticed product lot of inspire oxygenator.Based on evidences collected, the activation of clotting phenomenon throughout the entire circuit was confirmed and reasonably assumed to have contributed to increase of resistance to blood flow experienced by customer.The complained failure was traced back to unexpected blood activation in the system, resulting in partial occlusion of filtering elements and reduction of open surface for blood flow.The blood activation/clotting issue is multifactorial phenomenon correlated with clinical procedure therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.Based on investigation results, no direct correlation between complained issue and any device-related malfunction could be established.From complaint database review, the defective rate is low and in line with what reported within relevant risk management file.Following the analysis above, no specific corrective action will be taken in place for time being.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9705110
• MDR Text Key: 179231454
• Report Number: 9680841-2020-00005
• 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
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 03704
• Device Lot Number: 1907250031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 47 YR
• Patient Weight: 63