MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-80

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Review of the dhr did not identify any non conformities relevant to the reported issue.A livanova field service engineer was dispatched to the facility and confirmed the issue when warm cardioplegia pump was turned on.Water flooded the cardioplegia bridge, then spilled onto the lower part of the 3t, eventually dripping on the floor.After device inspection, black rubber tubing was found to be deformed and slipped off the output nozzle of the pump head.To solve the issue, affected tubing was replaced and, after performing all the functional tests with positive results, unit was sent back to customer in its expected function.Based on all the above facts , reported fluid leak was caused by black rubber tubing deterioration due to wear.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t was leaking a big amount of water during maintenance.There was no patient involvement.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 11423267
• MDR Text Key: 243815146
• Report Number: 9611109-2021-00106
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• 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: 03/02/2021

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: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1