MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL STOCKERT-SHILEY AORTIC ROOT CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number R501-15

Device Problem Disconnection (1171)

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

Event Date 02/27/2022

Event Type  malfunction  

Manufacturer Narrative

Follow up with customer clarified that the proximal connector and the cannula body disconnected, the leak was conspicuous for a moment after disconnection until assistant notice it and occluded the cannula ending.The previous 2 events occurred on different patients in different occasions.The bleeding period was very short in all three cases; no significant complications happened, and no additional measures were required.Three (3) patients are doing without event-related complications.The three involved devices are available and have been requested for investigation and not yet received.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report of blood leakage at the proximal connection of the antegrade aortic root cardioplegia cannulae during a surgery.Livanova has been informed that this event has happened two (2) additional times with the same lot.Livanova has been informed for the first time of the previous two events.Follow up with customer clarified that the proximal connector and the cannula body disconnected.There is no report of any patient injury for all events.

Event Description

See initial report.

Manufacturer Narrative

Based on investigation, the disconnection was ascribable to an assembly issue.The manufacturing personnel will be involved in a dedicated training meeting awaring of customer complaint.The risk is in the acceptable region.No other corrective action is deemed necessary.

Event Description

See initial report.

Manufacturer Narrative

The complained cannulae were returned to livanova for investigation.Visual inspection of returned cannulae confirmed the bonding failure between butterfly and cannula tubing.Parts got easily detached after gentle handling/manipulation.Traces of solvent (cyclohexanone) were visible on both of involved components.32 unused devices of batch concerned were returned by customer for evaluation.A pull-test has been manually performed on all devices, (b)(4)% were found to be assembled properly and (b)(4)% units were found to be faulty, exhibiting the same problem of complained units.Based on observed findings, the root cause of reported event was assigned to inadequate distribution of solvent by operator in manufacturing line when gluing these components together.Therefore, an awareness form to retrain production personnel about occurred misassembly event will be issued.

Manufacturer Narrative

Sorin group italia has received a report that the proximal connector and the cannula body disconnected during a procedure.To prevent re-occurrence, the livanova cannulae manufacturing department has identified as improvement action the introduction of an additional assembly visual check to be carried out after the gluing step (application of solvent) and before the final drying phase.The visual check will be performed by an operator different from the one who executed the assembly operation.The relevant manufacturing procedure will be updated accordingly.This process change will be effective q1 2023.

Event Description

See initial report.

• Brand Name: STOCKERT-SHILEY AORTIC ROOT CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: 14021336
• MDR Text Key: 288663269
• Report Number: 9680841-2022-00020
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 08033178004039
• UDI-Public: (01)08033178004039(17)240918(10)2109200051(11)210920(240)R501-15
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/27/2022

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: R501-15
• Device Catalogue Number: R501-15
• Device Lot Number: 2109200051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 06/21/2022; 07/25/2022; 12/01/2022
• Supplement Dates FDA Received: 07/14/2022; 08/23/2022; 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• 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