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 Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The bcd vangaurd (item 050229, lot number 1603220029) is a non-sterile device that was assembled into a convenience pack (catalog 084103204, lot 1610500034) and sterilized before distribution and use in the usa.Expiration date (mm/dd/yyyy) of convenience pack: 04/30/2018.(b)(4).Device manufacture date (mm/dd/yyyy) of the convenience pack: 04/14/2016.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).According to technical documentation of the convenience pack into which the cardioplegia unit was assembled, the transducer is not included in the pack.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 during a procedure.The medical team elected to change the transducers and were able to complete the case without changing the cardioplegia unit.There was no report of patient injury.

Manufacturer Narrative

The age of the device was calculated as the time elapsed from device sterilization and the date of event.(b)(4).(b)(4) the bcd vanguard blood cardioplegia system.The incident occurred in (b)(6).As per expemption number (b)(4), sorin group (b)(4) is submitting follow-up report for both (b)(4).On october 20, 2016, sorin group usa received the bcd vanguard for evaluation.Visual inspection identified wax bone onto the top valve of the device.Simulated use testing could not be performed due to the presence of bone wax on the top valve.A dhr verification 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.As the device could not be tested an exact root cause could not be determined.However, despite the low defect rate for this type of issue, sorin group (b)(4) initiated a capa to identify the root cause.The capa investigation found that this type of problem is likely related to a non-perfectly seated top valve.According to traceability, the claimed unit has been manufactured prior the implementation of the 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 S.R.L.; 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: 6072158
• MDR Text Key: 58933571
• Report Number: 9680841-2016-00512
• 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: 11/02/2016
• 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: 1601210101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/27/2017
• Device Age: 5 MO
• 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