MAUDE Adverse Event Report: SORIN GROUP USA CARDIOPLEGIA ADAPTER CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	CA-20010
Medical Device Problem Codes	Fluid/Blood Leak (1250); Increase in Pressure (1491); No Flow (2991)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Sorin group received a report that the cardioplegia adapter cannula was blocked and caused over-pressurization and blood leakage during a procedure.The device was switched out twice, and the issue recurred both times.On the third occurrence, the user noticed that the y-connector was blocked.The patient lost a significant amount of blood, and the procedure was extended by 40 minutes.The investigation is on-going.A follow up report will by submitted when the investigation is complete.
Event or Problem Description
Sorin group received a report that the cardioplegia adapter cannula was blocked and caused over-pressurization and blood leakage during a procedure.The device was switched out twice, and the issue recurred both times.On the third occurrence, the user noticed that the y-connector was blocked.The patient lost a significant amount of blood, and the procedure was extended by 40 minutes.
Additional Manufacturer Narrative
One cardioplegia adapter was returned to sorin group usa for evaluation.Visual inspection of the returned device confirmed an occlusion in the male luer of the short line of the cannula.The occlusion was determined to be caused by uv adhesive inside the lumen of the line.This was a manufacturing error.Sorin group has established capa (b)(4) to further investigate and review the application methods and ultraviolet bonding procedures of the uv bonding process.

• Brand Name: CARDIOPLEGIA ADAPTER CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6018809
• Report Number: 1718850-2016-00393
• Device Sequence Number: 16166246
• Product Code: DWF
• UDI-Device Identifier: 00803622103650
• UDI-Public: 00803622103650
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2016

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: 05/31/2019
• Device Catalogue Number: CA-20010
• Device Lot Number: 1612300121
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 01/13/2017
• 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: Other