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

Catalog Number 050228

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The bcd vanguard (item 050229, lot number unknown) 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.Sorin group (b)(4) manufactures the sorin biomedica smarxt bcd vanguard.The hospital where the incident occurred was (b)(6).Sorin group (b)(4) was informed by the distributor (b)(4).(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, after infusion of cardioplegic solution, during the cardioplegia standby, air was detected in the upper part of the bcd vanguard.There is no report of any patient injury.

Event Description

See intial report.

Manufacturer Narrative

Sorin group italia manufactures the sorin biomedica smarxt bcd vanguard.The hospital where the incident occurred was tokushima university hospital, tokushima, japan.Sorin group italia was informed by the distributor senko, tokyo, 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: 8281012
• MDR Text Key: 136740372
• Report Number: 9680841-2019-00002
• Device Sequence Number: 1
• Product Code: DTR
• 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: 04/26/2019

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 Catalogue Number: 050228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2018
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1