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

Catalog Number CA-20010

Device Problems Fluid/Blood Leak (1250); Increase in Pressure (1491); No Flow (2991)

Patient Problem Blood Loss (2597)

Event Date 09/13/2016

Event Type  malfunction  

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 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.

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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6018809
• MDR Text Key: 57047055
• Report Number: 1718850-2016-00393
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622103650
• UDI-Public: 00803622103650
• 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: consumer
• Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CA-20010
• Device Lot Number: 1612300121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2016
• 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
• Patient Outcome(s): Other