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

Model Number 16-02-95

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.The heater-cooler 16-02-95 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova (b)(4) has been informed that the device had water leak from the plastic l-shaped part of the 10mm hose.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report about water leaked from the plastic l-shaped part of the 10mm hose.

Event Description

See initial report.

Manufacturer Narrative

H.10: the hose and the connector were replaced and the issue could be solved.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• MDR Report Key: 9542935
• MDR Text Key: 196122283
• Report Number: 9611109-2020-00002
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-95
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Patient Sequence Number: 1