MAUDE Adverse Event Report: SORIN GROUP USA, INC. CUSTOM PERFUSION TUBING SET; CARDIOPULMONARY BYPASS CUSTOM TUBING KIT

Catalog Number	065254600
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.The device has been returned to sorin group usa for evaluation.If any additional information pertinent to the reported event is received, it will be submitted in a supplemental report.
Event or Problem Description
Sorin group received a report that the outlet port of the arterial filter in the custom perfusion tubing set was identified to be broken during setup.There was no patient involvement.
Additional Manufacturer Narrative
One av line including an adult arterial filter was returned to livanova usa for evaluation.The outlet port of the filter was confirmed to be broken off flush with the base of the port.The attached tubing was not pushed all the way on and there was no whitening of the plastic.The break appeared to be a clean and sharp.All product incorporated within the livanova usa pts tubing packs are closely and carefully inspected during assembly and pack-out, and the heart lung pack tray is specifically designed to protect the contents during routine shipping and handling stresses.Additionally, symbols are clearly placed on the over-shipper, indicating that the contents are delicate medical product.This broken port indicates rough handling after release from livanova.In an effort to further address this issue, the print drawing for this 065254600 catalog number was updated with additional photographs to clarify the proper placement of the arterial filter and its saddle within the pack to afford optimum protection to the component during transport.This lot number was for a total build of forty (40) packs and this is the only complaint received against this lot number.The damage to this product occurred after release from livanova.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Common Device Name: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 6726741
• Report Number: 1718850-2017-00013
• Device Sequence Number: 19078463
• Product Code: DWE
• UDI-Device Identifier: 10803622107433
• UDI-Public: (01)10803622107433(240)065254600(17)190331(10)1708200050
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: 03/31/2019
• Device Catalogue Number: 065254600
• Device Lot Number: 1708200050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1