MAUDE Adverse Event Report: SORIN GROUP USA, INC CUSTOM PERFUSION TUBING SET; CARDIOVASCULAR PROCEDURE KIT

Catalog Number	044035102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802); Blood Loss (2597)
Date of Event	03/03/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The involved disposable custom perfusion tubing set has been sent to sorin group usa for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group received a report of a leak from the "pronto" line of the customer perfusion tubing set, which resulted in approximately 2l of blood loss.The hospital reported that the patient had a stroke the day after the procedure and later expired.It is unknown if the stroke or death are related to the reported leak.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6432989
• Report Number: 1718850-2017-00005
• Device Sequence Number: 500842
• Product Code: OEZ
• UDI-Device Identifier: 00803622130342
• UDI-Public: (01)00803622130342(240)044035102(17)190131(10)1700600029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/27/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 044035102
• Device Lot Number: 1700600029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 03/24/2017
• 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: Death; Other
• Patient Weight: 83