MAUDE Adverse Event Report: SORIN GROUP USA D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number 050527

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group received a report that the outlet port of the arterial filter was found to be cracked off after the package was opened.There was no patient involvement.The device has been requested for further investigation.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the outlet port of the arterial filter was found to be cracked off after the package was opened.There was no patient involvement.

Manufacturer Narrative

Sorin group received a report that the outlet port of the arterial filter was found to be cracked off when the package was opened.There was no patient involvement.The device was returned to sorin group usa for investigation.Visual inspection of the returned device confirmed the reported issue.Sorin group usa has initiated a capa ((b)(4)) to evaluate arterial filter port breaks.The investigation found that port strength was shown to increase if the tubing / solvent is not pushed completely to the shoulder of the port.A fixture specific to this assembly process was implemented on january 5, 2016.This device was manufactured before implementation of the fixture.

• Brand Name: D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): SORIN GROUP USA; 14401 w. 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: 5505888
• MDR Text Key: 40664125
• Report Number: 1718850-2016-00110
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 050527
• Device Lot Number: 1506250154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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