MAUDE Adverse Event Report: SORIN GROUP ITALIA SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Catalog Number 050556

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 04/07/2014

Event Type  Other  

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) manufactures the sorin vvr 4000i and 4000i smarxt filtered hardshell venous reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the venous port of the sorin vvr hardshell venous reservoir was found to be broken off upon opening the packaging.The unit was not used for the procedure.There was no pt involvement.

• Brand Name: SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA; via staatale 12 nord, 86; mirandola ; IT
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3855564
• MDR Text Key: 19393980
• Report Number: 1718850-2014-00151
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 050556
• Device Lot Number: 1309270004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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