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

Model Number 16-02-85

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2016

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 (b)(4) received a report that the sorin heater-cooler system 3t displayed several unknown error codes during the disinfection cleaning process and the pumps stopped working.There was no patient involvement, as this issue occurred during maintenance.A sorin group field service representative was dispatched to the facility to investigate.The unit was run and functional checks were performed.The issue could not be duplicated.A technical safety inspection was performed and the unit was put back into use.This complaint was forwarded to the supplier ((b)(4)), who confirmed that the reported issues are related to the same root cause.However, without knowing which error codes appeared, a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported failure.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.Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that the sorin heater-cooler system 3t displayed several unknown error codes during the disinfection cleaning process and the pumps stopped working.There was no patient involvement, as this issue occurred furing maintenance.

• 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: 5766900
• MDR Text Key: 48717065
• Report Number: 9611109-2016-00417
• 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: 06/03/2016

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: 16-02-85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2011
• 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