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

Catalog Number	044017601
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up communication, sorin group learned that the device is not available for return.Additionally, no inventory has been identified to be used for investigation.If any additional information relevant to the reported issue is received, it will be provided in a supplemental report.Device not available for return.
Event or Problem Description
Sorin group received a report that the arterial line tubing of the custom perfusion tubing set disconnected during a procedure.The disconnection occurred just outside of the pump raceway on the positive pressure side.The perfusionist reconnected the tubing and tie-banded the connection.There was no report of patient injury.
Additional Manufacturer Narrative
A review of the photograph provided by the customer showed that ties had been placed on both sides of both 3/8 x ½¿ reducer connectors, but did not show the leak or identify the leak site.No inventory of this lot number was identified as available for investigation.There are several causes that could have led to the reported disconnection or leak.Without the involved product or representative inventory for an in-depth evaluation, a specific root cause could not be determined.Livanova usa decided a capa was not needed.There have been no other reports for leaks or disconnections against this catalog number or lot number.

• 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: 6749136
• Report Number: 1718850-2017-00014
• Device Sequence Number: 16417860
• Product Code: DWE
• UDI-Device Identifier: 00803622123887
• UDI-Public: (01)00803622123887(240)044017601(17)190430(10)1710800090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 044017601
• Device Lot Number: 1710800090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1