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

Catalog Number 050229

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The bcd vanguard (item 050229, lot number 1603220029) is a non-sterile device that was assembled into a convenience pack and sterilized before distribution and use in the usa.The catalog number for the pack is 084103204, however the lot number is unclear.Two lot numbers were reported (1610500034 and 1616700028), and it is unknown which pack this bcd vanguard device was assembled into.Expiration date (mm/dd/yyyy) for convenience packs: lot 1616700028 - 06/30/2018, lot 1610500034 - 04/30/2018.Unique identifier (udi) number for the convenience packs: lot 1616700028 - (b)(4), lot 1610500034 - (b)(4).The sorin biomedica smarxt bcd vanguard was assembled into a convenience pack distributed in usa.The non-sterile cardioplegia heat exchanger is also distributed in the usa (510(k)number: k021830).Device manufacture date (mm/dd/yyyy) for the convenience packs: lot 1616700028 - 06/15/2016, lot 1610500034 - 04/14/2016.Sorin group (b)(4) manufactures the sorin biomedica smarxt bcd vanguard.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that air was pulled into the top cap of the vanguard blood cardioplegia system where the valve is.This issue occurred on two different devices of the same lot.There was no report of patient injury.As no device was made available for return to sorin group (b)(4), physical investigation of the unit was not possible.Per the complaint description, the event that occurred at the customer site was air intake into the unit due to the umbrella valve on top of the unit not functioning correctly.A dhr verification did not highlight any relevant information regarding the reported issue.During production, 100% of bcd vanguard units are tested twice (in two different steps of manufacturing) for conformance of the functionality of the umbrella valve.Traceability of the complained unit (finished products and raw materials) did not identify a root cause.Sorin group (b)(4) has concluded that the problem may be related to a non-perfectly seated umbrella valve.As the device was not returned, an exact root cause could not be determined.Despite the low defect rate for this type of issue, sorin group (b)(4) has opened a capa to identify the root cause for this issue.Sorin group (b)(4) will continue to monitor for reports for this type of issue.Device not available for return.

Event Description

Sorin group (b)(4) received a report that air was pulled into the top cap of the vanguard blood cardioplegia system where the valve is.This issue occurred on two different devices of the same lot.There was no report of patient injury.

• Brand Name: SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; miradola (modena) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6064094
• MDR Text Key: 58722096
• Report Number: 9680841-2016-00509
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050229
• Device Lot Number: 1603220029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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