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

Catalog Number CA-40020

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/27/2023

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 kansas city, kansas.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.

Manufacturer Narrative

H10: through follow-up communication livanova learned that the leaks were both from the y and the luer connections.It appeared to the perfusionist that there wasn¿t proper bonding when it leaked at those connections.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18417448
• MDR Text Key: 331692010
• Report Number: 1718850-2023-00042
• 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
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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
• Date Manufacturer Received: 11/30/2023
• 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