MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL D901 DIDECO LILLIPUT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D901 + ADAPTORS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Sorin group (b)(4) manufactures the d901 dideco lilliput hollow fiber oxygenator.The incident occurred in (b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation.The review of the dhr of the oxygenator lot confirmed that the device was released in compliance with manufacturer specifications.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group (b)(4) has received a report that, after 3 minutes on bypass, blood was detected at the oxygenator gas outlet.The medical team elected to administer bank blood to maintain patient hematocrit.The procedure was completed with no issue.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The reported failure was a leak from the gas escape of d901 dideco lilliput oxygenator during a procedure.At the submission of the case, the customer has provided pictures and video which confirm the claimed issue.Livanova has requested the complained oxygenator for investigation.However, the customer has returned one (1) d901 dideco lilliput oxygenator belonging to a different lot rather than the complained oxygenator.Clarification on the origin of the device provided has been requested.The reported failure was confirmed based on the pictures provided by the customer at the submission of the case.Based on previously investigated similar cases, livanova believes the most probable root cause of the leakage is a damaged oxygenating fiber.Dhr review did not identify issue possibly related to the reported failure: the involved device was manufactured and released conforming to specifications.Accordingly, no further complaint was received relevant to the claimed lot of product.Review of the d901 dideco lilliput oxygenator manufacturing process suggested that a possible trigger of the damaged fiber was an improper use of a tool in contact with the fiber during initial phase of winding onto the oxygenator core.This damage is not detectable during the 100% in-process leak test.However, subsequent sterilization, shipping and ageing could enhance the fiber damage, resulting in a small leak when the device is used.Despite the overall of harm is low (incredible) and risk associated is acceptable, as a part of continuous improvement the standard operating manufacturing procedure has been revised to include handling prescriptions of the assembly tool.The complained oxygenator was manufactured before implementation of the improvement action.Livanova will keep monitoring the market.

• Brand Name: D901 DIDECO LILLIPUT
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9160818
• Report Number: 9680841-2019-00034
• Device Sequence Number: 1848893
• Product Code: DTZ
• UDI-Device Identifier: 08033178100274
• UDI-Public: (01)08033178100274(17)220223(10)1902200124
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K953835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: D901 + ADAPTORS
• Device Catalogue Number: 05318
• Device Lot Number: 1902200124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO