MAUDE Adverse Event Report: SORIN GROUP USA, INC CUSTOM PERFUSION TUBING SET; CARDIOVASCULAR PROCEDURE KIT

Catalog Number	044035102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802); Blood Loss (2597)
Date of Event	03/03/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The involved disposable custom perfusion tubing set has been sent to sorin group usa for investigation.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 received a report of a leak from the "pronto" line of the customer perfusion tubing set, which resulted in approximately 2l of blood loss.The hospital reported that the patient had a stroke the day after the procedure and later expired.It is unknown if the stroke or death are related to the reported leak.
Additional Manufacturer Narrative
Livanova usa followed-up with a medical expert for an analysis of the event.During this communication, the medical expert stated that it was his medical opinion that the reported leakage was not the cause of the stroke, and therefore, was not a contributor to the patient death.While it was indicated that 2l of blood loss from the arterial line is significant, it was expressed that this blood loos could be replaced without a long period of low or no flow, and that blood loss itself would not cause a stroke unless air or other particles were aspirated into the line, which is "very unlikely." additionally, in the unlikely event that this were to occur, it was stated that the reservoir, oxygenator or arterial filter should have removed any air that was introduced.The involved leaking components were returned to livanova for evaluation.Visual inspection with a black light indicated the presence of hl cement on the rigid y connector at all connection locations.Component leak testing was performed with air and the leak location was identified.Further inspection was carried out on a lab sample which had the same connector and tubing.Analysis of the bond under a black light showed a similar distribution of hl cement.(b)(4) additional samples were manufactured for further testing.These samples were manufactured in alignment with the applicable manufacturing operating procedure.All (b)(4) samples were inspected under a black light and all showed a similar distribution of hl cement to the complaint product.This indicates that the solvent was applied to the complaint product in accordance with the procedure.Burst testing was conducted on samples of tubing/y which were unsecured (no hl cement used), partially bonded, and fully bonded.This testing found that even with no hl cement, the tubing withstood 50+ psi before bursting.When fully bonded, the line could withstand pressures of 85psi or more before bursting.All of these values are well above the tested pressure rating of 10psi for pts packs, indicating that a lack of adhesive was not likely a contributing cause of the reported issue.The assembly process for this product was also reviewed.The dhr for the reported lot was analyzed and no deviations or deficiencies were noted.The hl cement used during the time frame of the pack build was also reviewed, and there were no deviations or deficiencies found in the hl cement dhr¿s.Based on the dhr reviews and the inspection of all the returned product and product samples, the assembly process appears to have been carried out according to specification.A review of the design of the line that experienced the leak found that it utilizes two y connectors, which are solvent bonded to tubing without a tie band on the connectors.The connector barbs and tubing inner diameter of the returned product were verified to be within specification.Livanova usa attempted to reach out to the customer for additional information to better understand the event and the potential causes of the reported patient stroke and death.However, due to on-going litigation, the customer has stated that they are unwilling to provide additional information.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6433016
• Report Number: 1718850-2017-00006
• Device Sequence Number: 13591062
• Product Code: OEZ
• UDI-Device Identifier: 00803622130342
• UDI-Public: (01)00803622130342(240)044035102(17)190131(10)1700600029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 044035102
• Device Lot Number: 1700600029
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Weight: 83