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.

• 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; 14404 w. 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 6018807
• MDR Text Key: 57103491
• Report Number: 1718850-2016-00392
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622103650
• UDI-Public: 00803622103650
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• 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
• 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