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

Model Number 16-02-80

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 01/18/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.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: (b)(4)).Sorin implemented a field safety notice for disinfection and cleaning of sorin heater cooler devices.The z number is (b)(4).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 was found to be contaminated with mycobacteria chimaera.No patient information was provided.The unit will be returned to sorin group (b)(4) for deep disinfection.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the sorin heater-cooler system 3t was found to be contaminmated with mycobacteria chimaera.No patient information was provided.

Manufacturer Narrative

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).The unit in question (b)(4) was returned to sorin group (b)(4) for deep disinfection.Visual inspection of the device identified residuals and biofilm in the device, especially in the patient tank, and microbiological sampling confirmed contamination of the device.A deep disinfection process was performed, the internal tubing was replaced and the unit was returned to the customer.Through follow-up communication with the customer, sorin group (b)(4) learned that the unit was removed from service and the customer is now using a device from another vendor.Based on the obvious biofilm identified in the water circuits of the three returned devices, sorin group (b)(4) has concluded that the users have not strictly followed the cleaning and disinfection instructions according to 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, a field safety notice 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).Unit removed from service by customer.

• 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: 5442931
• MDR Text Key: 38993876
• Report Number: 9611109-2016-00094
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

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: 16-02-80
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2009
• 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