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

Model Number 16-02-80

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Pma 510(k): 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).Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(4).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate.During inspection, the service representative found that the cardioplegia warm tank pump was completely melted and the unit was inoperable.The service representative was informed by the customer that the fire alarm was triggered manually when a hospital employee noticed the smell coming from the unit.The device has been requested for return to sorin group (b)(4) for further investigation.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report, that a fire alarm was triggered in the screening room of the hospital due to strong smell of burnt rubber/plastic coming from the vent of sorin heater-cooler system 3t.The outside casing of the sorin heater-cooler system 3t was very hot.The machine was kept by the facility as a backup unit and at the time of the incident was not used for procedures.There was no patient involvement.

Manufacturer Narrative

The involved device was returned to livanova (b)(4) for further investigation.During the evaluation, the error could not be reproduced.However, two damaged resistors were identified, which became high-impedance, caused the electronics of the protection system to go into an oscillating reset state.The fault state that reportedly led to uncontrolled heating was likely the result of the damaged resistors and additional unknown, non-reproducible influencing factors.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6125889
• MDR Text Key: 60864430
• Report Number: 9611109-2016-00851
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Hospital Service Technician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• 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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2000
• 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