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.

• 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: 6018807
• Report Number: 1718850-2016-00392
• Device Sequence Number: 13471638
• Product Code: DWF
• UDI-Device Identifier: 00803622103650
• UDI-Public: 00803622103650
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2016
• Initial Report FDA Received Date: 10/11/2016
• 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