MAUDE Adverse Event Report: SORIN GROUP ITALIA SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Catalog Number 050229

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There was no patient involvement.At the date of the present report, the unit has not been returned to sorin group (b)(4) for investigation.Sorin group (b)(4) manufactures the bcd vanguard blood cardioplegia system.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that air was seen in the purge line of the bcd vanguard during priming.The unit was changed out to continue the set-up for the procedure.There was no patient involvement.The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that air was seen in the purge line of the bcd vanguard during priming.The unit was changed out to continue the set-up for the procedure.There was no patient involvement.

Manufacturer Narrative

(b)(4) manufactures the bcd vanguard blood cardioplegia system.The incident occurred (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that air was seen in the purge line of the bcd vanguard during priming.The unit was changed out to continue the set-up for the procedure.There was no patient involvement.The complained device was returned to sorin group usa for investigation.Visual inspection did not identify any defects or abnormalities.The unit was returned to sorin group (b)(4) for further investigation, where visual inspection identified that the top white lid of the unit had been completely covered with bone wax by the customer.No other abnormalities were observed.A depriming test was performed to evaluate the functionality of the umbrella valve and the reported issue could not be reproduced.The valve had become incoporated into the bone wax, preventing the investigator from replicating the original setup.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The product was manufactured in accordance with the defined specifications.Although no defect was identified on the returned device, sorin group (b)(4) has initiated a capa to investigate this type issue.

• Brand Name: SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (mo), italy 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5523958
• MDR Text Key: 41125159
• Report Number: 9680841-2016-00162
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021830
• 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: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2016
• Device Catalogue Number: 050229
• Device Lot Number: 1509230115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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