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 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Event occurred prior to any patient involvement.The bcd vanguard (item 050228, lot number 1810260092) 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 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.

Event Description

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

Event Description

See intial report.

Manufacturer Narrative

H.10: sorin group italia manufactures the sorin biomedica smarxt bcd vanguard.The event occurred shibata, japan.The complained bcd vanguard was returned to livanova for investigation.During visual inspection it has identify the white protective cap was disassembled from the umbrella valve on top area and was loose inside package.Visual inspection on umbrella valve found no deformation nor any obvious damage.The bcd vanguard was filled with blue methylene dry solution and verified if air was entering in the device.Laboratory test could not reproduce the claimed air intake.However, a leak was identified by the top portion of air chamber, in proximity to welding profile.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Based on previous investigation, the root cause of this type of leak was a weakening of ultrasonic welding of polycarbonate lid and body of air chamber.To further decrease the frequency of this type of leakages, matching of the air chamber components has been improved and a mould maintenance have been performed.The frequency of this type of leak is low.No corrective action will be undertaken.Livanova will keep monitoring the market.

• 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, modena
• MDR Report Key: 9510679
• MDR Text Key: 217433334
• Report Number: 9680841-2019-00045
• 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: 04/15/2020

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: 1810260092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1