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

Catalog Number 050228J

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

The event occurred prior to any patient involvement.The bcd vanguard (item#: 050228, lot number: unknown) is a non-sterile device that was assembled into convenience pack manufactured by a (b)(4) assembler (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 in (b)(6).The involved device has not 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 italia has received a report that, during priming, air was seen in the top part of the bcd vanguard cardioplegia exchanger.The issue occurred prior to patient involvement.

Event Description

See initial report.

Manufacturer Narrative

Livanova received a report stating that air was drawn into the vanguard device during priming.No patient or user was affected.A confirming video was provided.During the test, the outlet side of the heat exchanger was clamped, priming was carried out from the inlet side of the heat exchanger, and the heat exchanger was filled with water.The outlet side was clamped, the inlet side was released, and the water level in the heat exchanger was checked with a head pressure.From the air filter to the outlet of the outflow tract, a 100 cm, 50 cm, 20 cm height was used to check.At jms the issue was confirmed, in particular the priming solution flowed out from the inlet port and the water level inside the device was decreased.No device service history review was performed since no lot number was provided.Based on the facts above, it cannot be ruled out that the most likely root cause of the reported issue are: damaged umbrella valve.Accidental misplacement of the umbrella valve.No specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.H3 other text : investigation performed by assembler.

Event Description

See initial report.

Manufacturer Narrative

The involved bcd vanguard, labeled with shop order (b)(4) was received at livanova facility for investigation.From visual inspection, bubbles were observed around the umbrella valve at the top of device.The device has been returned with the white protective cap correctly assembled from the umbrella valve on top area.After the test the umbrella valve has been visually inspected and no deformations nor damages have been found on this component.Investigation result confirmed amptying of device from inlet connector and water dripping from top area.Livanova believes the most likely root cause of the reported issue is a potential mix-up in production line between good umbrella valve with a pinched or not perfectly seated umbrella valve in its dedicated housing.The residual risk is still acceptable.Livanova will maintain to 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: 10875411
• MDR Text Key: 223610203
• Report Number: 9680841-2020-00016
• 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,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050228J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1