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

Model Number 16-02-80

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but 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).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported event.Through follow-up communication livanova (b)(4) learned that it was a schuko plug and that a possible cause could be a combination with wall outlet, bad connection that doesn¿t take high current.The power cable will be replaced in order to solve the issue and a new plug will be fitted.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 (b)(4) received a report of a heater-cooler system 3t power cable smelling and melting during use.There was no report of patient injury.

Manufacturer Narrative

H.10: during the investigation performed by the manufacturer it was confirmed that one pin of the mains connector was exposed to large heat.The heat effect took place with high probability from the outside over the pin to the inside.From an electrical point of view, the plug and the cable were in good conditions, thus, no damage except for the fused point on the plug.The cause of the damage was very likely a faulty hospital wall outlet.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 9225630
• MDR Text Key: 194493285
• Report Number: 9611109-2019-00842
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1