MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Catalog Number 050556

Device Problem Increase in Pressure (1491)

Patient Problem Death (1802)

Event Date 09/03/2016

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.The vvr4000i smarxt hp reservoir (lot number 1602050118) is a non-sterile device that was assembled into a convenience pack (catalog 084118102, lot 1616500047 or 1617400034) and sterilized before distribution and use in the usa.Expiration date (mm/dd/yyyy) for both convenience pack lots: 06/30/2018.Unique identifier (udi) number for the convenience packs: lot 1616500047 - (b)(4).Lot 1617400034 - (b)(4).Device manufacture date (mm/dd/yyyy) for the convenience packs: lot 1616500047 - 06/13/2016.Lot 1617400034 - 06/22/2016.The sorin vvr 4000i smarxt was assembled into a convenience pack distributed in usa.The non-sterile reservoir is also distributed in the usa as a sterile device (510(k)number: k092315).Sorin group (b)(4) manufactures the sorin vvr 4000i smarxt hardshell venous reservoir.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that, during a procedure, the blue cap on the cardiotomy port was blown off due to over-pressurization of the sorin vvr 4000i smarxt hardshell venous reservoir.Blood and foam were sprayed in the operation room.The reservoir was changed out and the bypass was re-initiated.Reportedly the event occurred while the patient was off by-pass.At the end of the procedure, the patient was put in ecmo and transferred in icu.The patient died after the procedure.The cause of death is unknown, however the perfusionist has stated that it is not believed the outcome of the patient is associated with the failure of the device.The device has been returned to sorin group (b)(4) and the investigation is in progress.A follow-up report will be sent when the investigation has been completed.Device returned, not yet decontaminated.

Event Description

Sorin group (b)(4) received a report that, during a procedure, the blue cap on the cardiotomy port was blown off due to over-pressurization of the sorin vvr 4000i smarxt hardshell venous reservoir.Blood and foam were sprayed in the operation room.The reservoir was changed out and the bypass was re-initiated.Reportedly the event occurred while the patient was off by-pass.At the end of the procedure, the patient was put in ecmo and transferred in icu.The patient died after the procedure.The cause of death is unknown, however the perfusionist has stated that it is not believed the outcome of the patient is associated with the failure of the device.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin vvr 4000i smarxt hardshell venous reservoir.The incident occurred in (b)(6).Visual inspection of the reservoir at sorin group usa identified residual blood still inside the unit.No defects or abnormalities were detected.The device was returned to sorin group (b)(4) for further investigation, where simulated use testing found that the cardiotomy filter of the reservoir was partially occluded by clotted blood or biological material from the surgical field.However, no non conformities were noted during the control and testing phases.Sorin group (b)(4) has concluded that the most probable root cause of the event is associated with the filtration clotting phenomenon triggered by multiple factors such as patient blood features, clinical procedure and use condition.The use of co2 during the procedure, as described by the customer, can also trigger aggregate phenomena.Additionally, prolonged use of the device is not recommended per the instructions for use (ifu).Based on the pump sheet data for the event, the reservoir was used for 1.5 hours longer than the recommended use time.A dhr review confirmed that the device was manufactured, tested and released in compliance with standard manufacturing procedures.According to traceability, no other complaints have been received for this lot.Based on the result of the investigation, no corrective action has been deemed necessary.Sorin group (b)(4) will continue to monitor for this type of issue.

Manufacturer Narrative

On march 6, 2017, sorin group (b)(4) learned that a user medwatch report ((b)(4)) was filed by the initial reporter for this event.

• Brand Name: SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola (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: 5993802
• MDR Text Key: 56307440
• Report Number: 9680841-2016-00500
• Device Sequence Number: 1
• Product Code: DTN
• 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,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050556
• Device Lot Number: 1602050118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• 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
• Patient Outcome(s): Death