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

Model Number 16-02-80

Device Problems Insufficient Cooling (1130); Insufficient Heating (1287)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

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)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the heating and cooling capacity of the sorin heater-cooler system 3t was lower than the heating and cooling capacity of other sorin heater-cooler units used at the hospital.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.The device was tested and was found to be working correctly and was not heating or cooling differently than the other devices at the facility.The temperature sensors were cleaned and a temperature calibration was performed.A final functional check and test run found no issues.The unit was released to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.No parts replaced; unit in working order.

Event Description

Sorin group (b)(4) received a report that the heating and cooling capacity of the sorin heater-cooler system 3t was lower than the heating and cooling capacity of other sorin heater-cooler units used at the hospital.There was no report of patient injury.

Manufacturer Narrative

Due further available information this complaint has been re-evaluated and could be considered as not reportable.The initially reported insufficient performance was not relating to heating the patient.Therefore no hazardous situation can occur.

• 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: 5763782
• MDR Text Key: 48625787
• Report Number: 9611109-2016-00454
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2005
• 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