MAUDE Adverse Event Report: SORIN GROUP USA, INC. DUAL STAGE VENOUS RETURN CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number RDS-61137

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

Patient Problem No Patient involvement (2648)

Event Date 03/15/2015

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report from a clinician that during set-up, they felt that the connector was not fitting tight on the cannula and would disconnect it twisted.The product was not used.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) received a report from a clinician that during set-up, they felt that the connector was not fitting tight on the cannula and would disconnect if twisted.The product was not used.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) received a report from a clinician that during set-up, they felt that the connector was not fitting tight on the cannula and would disconnect if twisted.The product was not used.There was no patient involvement.Ten dual stage venous return cannulae, all manufactured by (b)(4), were returned to sorin group usa for evaluation.The returned cannulae were subjected to visual inspection and no defects were found.Measurements of the inner diameter were taken for 3 of the returned cannulae and it was found that the devices were out of specification at the location of the connector attachment.Through manual manipulation, the connector could be disconnected on each of the devices.The cause of this issue was identified to be out of specification tubing.The tubing was over-stretched when the cannulae were assembled by calmed labs.Calmed labs has been acquired by sorin group and product is no longer being produced by calmed.Sorin group usa manufacturing has implemented process improvements for stretching this tubing.All process changes have passed validation testing by sorin group usa prior to implementation and product release.There have been no reports regarding air entrainment against venous return cannula that was manufactured by sorin group usa.Sorin group has established a (b)(4), to further evaluate this connection point.

• Brand Name: DUAL STAGE VENOUS RETURN CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4857046
• MDR Text Key: 5850817
• Report Number: 1718850-2015-00180
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K943934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: RDS-61137
• Device Lot Number: S140007
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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