MAUDE Adverse Event Report: SORIN GROUP USA, INC AORTIC ARCH CANNULAS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	RA-xxxxx
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.The investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Photos received are sufficient.
Event or Problem Description
Sorin group received a report that the vent luer connector and the tip of the aortic arch cannula were found to not on the same plane during setup.They were at 120 degrees instead of 180 degrees.There was no patient involvement.
Additional Manufacturer Narrative
This event was originally classified as a reportable malfunction, as the initial complaint indicated that the tip was out of alignment with the orientation line.However, the investigation found that the tip was in fact correctly aligned with the orientation line, and it was the luer that was misaligned with the tip.The alignment of the luer with the tip is not critical; it is intended for convenience and is not intended as a locator.Based on the investigation, this event is no longer classified as reportable and this medwatch report is void.

• Brand Name: AORTIC ARCH CANNULAS
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6618668
• Report Number: 1718850-2017-00009
• Device Sequence Number: 18833768
• Product Code: DWF
• UDI-Device Identifier: 00803622105043
• UDI-Public: (01)00803622105043(240)RA-1137(17)200131(10)1700900153
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: RA-xxxxx
• Device Catalogue Number: RA-1137
• Device Lot Number: 1700900153
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1