MAUDE Adverse Event Report: LIVANOVA USA INC. CARDIOPLEGIA CANNULA ADAPTERS; AORTIC ROOT CANNULA, AIR ASPIRATOR, PERFUSION ADAPTER, VESSEL CANNULA

Catalog Number CA-40020

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

Livanova usa inc.Received a report that cardioplegia cannula adapters during procedure leaked in various areas, wherever the tubing connects to a connector, at the y or at the tip.Surgeons have been sprayed with blood.Affected units were changed out until one that didn't leak.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.D.4.Involved lot is 232400008 or 2326200052.This information will be provided in a supplemental report if made available.H10: livanova deutschland manufactures the cardioplegia cannula adapters.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

According to follow up, the leaking points were both from the y and the luer connections.It appeared to the perfusionists that there wasn¿t proper bonding when it leaked at those connections.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H11: correction in initial report mfr #1718850-2023-00041, h10 section: "livanova deutschland manufactures the cardioplegia cannula adapters." instead of "livanova usa inc.Manufactures the cardioplegia cannula adapters" due to human error.From complaints database review, three (3) other complaints (mfr #1718850-2023-00042, 1718850-2023-00043 and 1718850-2023-00041) related to the same issue were submitted from this facility, that occurred on consecutive days.One unit among those affected was returned by customer for investigation, however it did not have any traceability information, therefore it was not possible to distinguish to which of the two complained lots it belonged to.Visual inspection was performed: a clear leak path could be seen at the y-connector with the red and blue clamp.Each leg of the device was leak tested individually.The unit leaked out of the y-connector bond with the red and blue clamp.All luer connectors attached to the end of each of the legs did not leak.The review of similar cases highlighted that other previous complaints, not the ones mentioned above, were registered in the last 12 months reporting leaks from the y-connector, particularly from different customers and thus also on different cannula lots.Based on the investigation results from similar complaints, the event identified a leak at the connection between the y connector and the tubing.A gap between the two impacted components was observed and recognized as source of the leak.This connection is obtained through the use of uv adhesive during the manufacturing process.Also, all other tubing connections to luers and to the four-ways connector are solvent bonded.A capa was initiated for the issue of leaks from y-connector, and the investigation revealed the following findings: 1) uv adhesive flows from tube-to-connector joint before curing.2) variations in the quality of the connectors compromise the integrity of the bond.Corrective action will be implemented through the capa process.Regarding leaks from other bonded connections, the personnel will be involved in a dedicated training meeting about awareness of customer complaint.

• Brand Name: CARDIOPLEGIA CANNULA ADAPTERS
• Type of Device: AORTIC ROOT CANNULA, AIR ASPIRATOR, PERFUSION ADAPTER, VESSEL CANNULA
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 18417446
• MDR Text Key: 331591989
• Report Number: 1718850-2023-00041
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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 Catalogue Number: CA-40020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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