MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM; CARDIOPLEGIA HEAT EXCHANGER

Catalog Number 050228

Device Problem Gas Output Problem (1266)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred prior to any patient involvement.The bcd vanguard (item 050228, lot number 180328006) is a non-sterile device that was assembled into convenience pack (catalog number unknown) that is not distributed in the usa.The lot and the expiry date (mm/dd/yyyy) of the complained convenience pack are not known.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.Age of the device: as the lot is unknown, sterilization date could not be determined and the age of the device could not be calculated.(b)(4).The sorin biomedica smarxt bcd vanguard is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The non-sterile cardioplegia heat exchanger is also distributed in the usa (510(k)number: k934847).Device manufacture date (mm/dd/yyyy) of the convenience pack: as the lot number is unknown, the manufacture date could not be determined.(b)(4).The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not yet returned.

Event Description

Sorin group (b)(4) has received a report that, during priming, air was seen at the top of the cardioplegia heat exchanger bcd vanguard.The issue occurred priot to any patient involvement.

Manufacturer Narrative

Sorin group italia manufactures the sorin biomedica smarxt bcd vanguard.The event occurred nankoku, japan.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The complained bcd vanguard was returned to sorin italia for investigation.Visual inspection found not obvious problem nor defect.The bcd vanguard was filled and verified if air was entering in the device.Laboratory test could not reproduce the claimed problem.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova experience indicates that the problem could be related to a not-perfectly seated umbrella valve.The reasons for the incorrect seating of the valve might be an accidental excessive mechanical stress due to shipping/transportation.As the frequency of this type of event is low, no corrective action will be undertaken.Livanova will keep monitoring the market.

• Brand Name: SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
• Type of Device: CARDIOPLEGIA HEAT EXCHANGER
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8444637
• MDR Text Key: 139598146
• Report Number: 9680841-2019-00014
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050228
• Device Lot Number: 1803280063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/22/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1