MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL PROCEDURE SET TX/225; APPARATUS, AUTOTRANSFUSION

Model Number 04257

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, livanova has been informed that at the beginning of a procedure with an aneurysmal sac on a stent the xtra ats bowl exploded.Blood was sprayed in the xtra centrifuge equipment device and on medical personnel who was around.According to information, the lid of the xtra centrifuge equipment was closed since it is not possible to operate the equipment if the lid is not closed.The equipment and sanitary clothing were changed and the procedure was completed with no further issue the equipment was used in the morning without any difficulties encountered.The device was tested under normal conditions of use.This is the first time the team medical observes this type of incident.No consequences for the patient.Blood loss was nearly 100ml and procedure time slightly increased.

Manufacturer Narrative

Sorin group italia manufactures the xtra procedure set tx/225.The incident occurred in (b)(6).The involved device has been disposed by the customer.According to follow-up with the customer the bowl exploded at the 2nd procedure, the first went well with good volume and good htc output.They heard a big noise and explosion at the end of the filling process blood spurted everywhere and ran down the machine.Bowl exploded at the bottom.Due to the condition of the xtra our field service has exchanged the machine for a complete check and cleaning in our repair centre.Livanova has initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

No set up or operational error by user was reported.Exhaustive pictures confirming the issue was provided and confirmed the bowl burst.Extended report of xtra device is use during the case was not provided.Review of the manufacturing record of the complained disposable components were verified to be conforming to specifications.Review of the livanova complaints database did not identify any other similar event related to the complained lot.Based on all the above, the most likely root cause of reported event was an unexpected internal bowl pressure increase phenomenon reasonably triggered by clot formation inside the bowl clogging the outlet blood flow path, due to peculiar blood conditions (prone to get clotted) or inadequate anticoagulant dosage or prolonged blood stagnation period inside the circuit.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova livanova will keep monitoring the market.Disposed.

Event Description

See initial report.

• Brand Name: PROCEDURE SET TX/225
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15894516
• MDR Text Key: 307978126
• Report Number: 9680841-2022-00055
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04257
• Device Lot Number: 2203040183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2022
• 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