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

Model Number 16-02-85

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There was no patient involvement.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 deutschland received a report that the sorin heater-cooler system 3t displayed an error code on the patient side and the water did not circulate during priming.The unit was switched out for the procedure.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate and could not reproduce the reported error code.During examination the patient tank was found to be completely empty of water and the unit showed a level alarm.The service representative filled the tank to the correct level and the alarm ceased.All water circuits were found to be functioned normally.The pump connectors and distribution board were cleaned and all connections on the distribution boards for both bridges were reseated.The unit was run for several hours and no errors were observed.Preventive maintenance and functional verification were performed without issue and 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.As the issue could not be confirmed, a root cause was not determined and no corrective actions were identified.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

Event Description

Sorin group (b)(4) received a report that the sorin heater-cooler system 3t displayed an error code on the patient side and the water did not circulate during priming.The unit was switched out for the procedure.There was no patient involvement.

• 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): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5705092
• MDR Text Key: 46763011
• Report Number: 9611109-2016-00324
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• 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
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2011
• 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