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

Catalog Number 050228

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The bcd vanguard (item 050229, lot number 1804170038) 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.

Event Description

Sorin group (b)(4) has been informed that, after priming, a white particle was identified by the outlet of the cardioplegia heat exchanger bcd-vanguard.There is no report of any patient injury.

Manufacturer Narrative

Sorin group italia manufactures the sorin biomedica smarxt bcd vanguard.The event occurred in kashiwa, japan.Sorin group italia was informed by the distributor senko, tokyo, japan.Inspection of the returned device confirmed the presence of an extranous material in the priming solution by the bcd vanguard outlet connector.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The presence of the extraneous material is ascribable to a human error during the manufacturing and during the subsequent visual inspection steps that should have identified the extraneous material and discarded the unit.To prevent reoccurrence, the manufacturing operators will be retrained.The frequency of this type of event is low.Livanova will keep monitoring the market for similar events.

• 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: 8510135
• MDR Text Key: 146340683
• Report Number: 9680841-2019-00017
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• 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: 1804170038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1