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

Catalog Number 050228J

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred prior to any patient involvement.The bcd vanguard (item 050228, lot number 1901280054) 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.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.Sorin group (b)(4) manufactures the sorin biomedica smarxt bcd vanguard.The event occurred (b)(6.The involved device has been requested for nvestigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

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

Manufacturer Narrative

H.10 sorin group italia manufactures the sorin biomedica smarxt bcd vanguard.The event occurred (b)(6).The complained bcd vanguard was returned to livanova for investigation.Visual inspection found no problem nor any 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.Based on investigation results, no direct relationship between the complained event and any device related malfunction has been established.As no specific failure of the device to meet specifications has been reproduced and confirmed, no corrective action will be taken in place for the time being as the frequency of this type of event is low, no corrective action will be undertaken.Livanova will keep monitoring the market.

Event Description

See "initial" report.

• Brand Name: CARDIOPLEGIA HEAT EXCHANGER
• Type of Device: SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• MDR Report Key: 9510653
• MDR Text Key: 219203551
• Report Number: 9680841-2019-00043
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050228J
• Device Lot Number: 1812130043
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1