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

Model Number 16-02-80

Device Problem Biofilm coating in Device (1062)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There is no known patient involvement.Recall number: sorin implemented a field safety notice for disinfection and cleaning of sorin heater cooler devices.The z number is z-2076/2081-2015.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 received a report that biofilm was identified in the internal hoses of the sorin heater-cooler system 3t during maintenance.This issue was discovered by a sorin group field service representative while performing preventative maintenance.There is no known patient involvement.The service representative replaced the internal tubing of the device according to the preventative maintenance guidelines.A functional test was successfully performed and the unit was returned to service.Sorin group (b)(4) has determined that the root cause for this issue was a failure of the user to adhere to the cleaning and disinfection instructions outlined in the current instructions for use (ifu).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As corrective action, fsca 9611109-06/03/15-002-c was released to remind our customers about the importance of adhering to the water management and disinfection procedure outlined in the current instructions for use (ifu).Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that biofilm was identified in the internal hoses of the sorin heater-cooler system 3t during maintenance.This issue was discovered by a sorin group field service representative while performing preventative maintenance.There is no known 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: 6057294
• MDR Text Key: 58414381
• Report Number: 9611109-2016-00708
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 16-02-80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1