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

Model Number 16-02-85

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2016

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).A sorin group field service representative was dispatched to the facility to investigate.The service representative confirmed that the patient bridge power connector and the ac mains board were burnt.The customer confirmed that the facility had experienced a power surge on the event date.The defective components were replaced and subsequent functional testing did not identify further issues.The was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.No trend has been identified for this type of issue.Sorin group (b)(4) will continue to monitor for trends related to this issue.Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that a facility experienced a power surge which burnt the patient bridge power connector and the ac mains board of the sorin heater cooler system 3t during priming.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: joan ceasar ; 14401 w. 65th way; arvada,, CO 80004 ; 2812287260
• MDR Report Key: 6168443
• MDR Text Key: 62377616
• Report Number: 9611109-2016-00910
• 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: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2008
• 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