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

Catalog Number 044017601

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2017

Event Type  malfunction  

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 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.

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
• Type of Device: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6749136
• MDR Text Key: 81261513
• Report Number: 1718850-2017-00014
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622123887
• UDI-Public: (01)00803622123887(240)044017601(17)190430(10)1710800090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 044017601
• Device Lot Number: 1710800090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1