MAUDE Adverse Event Report: SORIN GROUP USA, INC. CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number CA-20070

Device Problems Partial Blockage (1065); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2015

Event Type  Other  

Manufacturer Narrative

Pt info was not provided.Sorin group received a report that during cardioplegia delivery there was no fluid coming out the cardioplegia tubing.The clinical specialist noted that where the luer connects to the tubing, it appeared blocked.There was no report of pt injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that during cardioplegia delivery there was no fluid coming out the cardioplegia tubing.The clinical specialist noted that where the luer connects to the tubing, it appeared blocked.There was no report of pt injury.

Manufacturer Narrative

Sorin group received a report that during cardioplegia delivery there was no fluid coming out the cardioplegia tubing.The clinical specialist noted that where the luer connects to the tubing, it appeared blocked.There was no report of patient injury.The involved cardioplegia wye line was returned to sorin group usa for evaluation.A visual inspection of the line confirmed that the female luer was completely occluded with the adhesive used for bonding.No other defects or abnormalities were found.There is no remaining inventory of this lot number.The reported issue was caused by a manufacturing error.The individuals responsible for assembling and inspecting this line were gathered together, the manufacturing operating procedure was reviewed, and the possible causes for this occlusion were discussed to ensure that the proper steps needed for this build were clearly understood.Sorin group usa has determined that a capa is not needed.There was no patient injury, no trend has been identified and a correction has been performed.Sorin group will continue to monitor the market for trends related to this issue.

• Brand Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5075021
• MDR Text Key: 26006337
• Report Number: 1718850-2015-00356
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CA-20070
• Device Lot Number: 1507900104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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