MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03707

Device Problem Medical Gas Supply Problem (2985)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The inspire 8 m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (catalog in00817, lot 1906250181) 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 age of the device was calculated as the time elapsed between device sterilization and the date of event.The complained inspire 8 m hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050701) is registered in the usa (510(k) number: k130433).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 8 hollow fiber oxygenator.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested but not received at sorin group (b)(4) facilities.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not yet returned.

Event Description

Sorin group (b)(4) has received a report that, during a procedure, gas analysis of blood sample showed low po2 levels despite continuous blood parameter monitor showed adequate po2 values.The medical team elected to change-out the oxygenator.The change-out occurred without interrupting the cec.There is no report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

Complained inspire 8 oxygenator was returned sorin italia for investigation and subjected to decontamination as per livanova procedure on blood contaminated goods.Simulated use test performed according to relevant standard confirmed the oxygenator performance were in line with product specifications: during livanova laboratory test the device behaved as expected.Dhr verification did not reveal any relevant information possibly related to the claimed issue.The complained lot was not involved in any other similar event.As per the evidences collected, the root cause of the event could not be traced to any device-related malfunction.Livanova believes a possible root cause of the issue experienced by the customer is multi-factorial, where a combination of triggering factors might be originating the phenomena, including interaction with clinical procedure and patient.As the occurrence of such kind of event is very low and a clear root cause could not be assessed, no corrective action will be undertaken.Livanova will keep monitoring the market for similar events.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8965439
• MDR Text Key: 210468490
• Report Number: 9680841-2019-00032
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Catalogue Number: 03707
• Device Lot Number: 1906240092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 53