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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
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.

 
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Brand NameSORIN HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, 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 Key5442931
MDR Text Key38993876
Report Number9611109-2016-00094
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-80
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/30/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2076/2081-2015

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