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

Catalog Number 050229

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The bcd vangaurd (item 050229, lot number 1602260145) is a non-sterile device that was assembled into convenience pack catalog number 044003200 and sterilized before distribution and use in the usa.The complained lot of bcd vangaurds was assembled into multiple lots of convenience pack 044003200, so the lot number is unknown.Expiration date (mm/dd/yyyy) of convenience pack: as the lot is unknown, the expiration date could not be determined.Device identifier (di) number for the convenience pack: 00803622111938.Device manufacture date (mm/dd/yyyy) of the convenience pack: as the lot number is unknown, the manufacture date could not be determined.The sorin biomedica smarxt bcd vanguard was assembled into a convenience pack distributed in the usa.The non-sterile cardioplegia heat exchanger is also distributed in the usa (510(k)number: k021830).Sorin group (b)(4) manufactures the sorin biomedica smarxt bcd vanguard.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that air was pulled into the top cap of the vanguard blood cardioplegia system and the unit emptied when it was exposed to a mild negative pressure during priming.There was no patient involvement.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the bcd vanguard blood cardioplegia system.The incident occurred in (b)(4).As per exemption number (b)(4).Sorin group (b)(4) is submitting follow-up report for both sorin group (b)(4) (manufacturer) and (b)(4).The bcd vanguard heat exchanger was returned to sorin group (b)(4) for evaluation.Visual inspection of the device did not reveal any defects.Simulated use testing was not able to replicate the reported depriming issue.However, leak testing identified a fluid leak from the top cap of the device.Fluid infiltration in that zone should not be allowed due to a hydrophobic membrane which separates top chamber into two compartments.The leak could be caused by an issue in the membrane.A dhr review did not highlight any relevant information regarding the reported issue.During manufacturing, 100% of bcd vanguard units are tested twice for correct functionality of the top valve.The reported depriming issue is not always reproducible due to movement of the top valve.Sorin group (b)(4) cannot exclude that the depriming reported by the customer was initially caused by the leak across the hydrophobic membrane, which can displace the top valve from its correct position.Despite the low defect rate for this type of issue, sorin group (b)(4) initiated a capa to identify the root cause for depriming.The capa investigation concluded that this type of problem is likely related to a non-perfectly seated top valve.As the event date was prior to the capa closure, it is likely that the convenience pack was manufactured prior to implementation of corrective actions.

• Brand Name: SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
• Type of Device: CARDIOPLEGIA HEAT EXCHANGER
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; miradola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA, SRL.; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6107548
• MDR Text Key: 60098434
• Report Number: 9680841-2016-00515
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050229
• Device Lot Number: 1602260145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/27/2017
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1