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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 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2015
Event Type  No Answer Provided  
Manufacturer Narrative
There is no known patient involvement.The user report did not specify an event date.However, follow-up communication with the customer revealed that the first positive test results were received on (b)(6) 2015.This date was selected as the event date.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).Through follow-up communication with the customer, sorin group (b)(4) learned that the heater-cooler tested positive for m.Chelonae on (b)(6) 2015 and for m.Immunogenum on (b)(6) 2016.The customer stated that the unit is used within the operation theatre directed away from the sterile field.The unit is still currently in use.The customer also stated that the water filter has been changed and weekly cleaning has been performed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
 
Event Description
On (b)(6) 2016, sorin group (b)(4) received a user medwatch report (mw5065908) stating that the sorin heater-cooler system 3t tested positive for mycobacterium chelonae and mycobacterium immunogenum.The report indicated that the cleaning and disinfection procedure is being followed per the manufacturer's recommendations.There is no known patient involvement.
 
Manufacturer Narrative
The facility address provided in the initial report, submitted december 23, 2016, was incorrect.The correct facility address is: (b)(6).
 
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Brand Name
SORIN HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich,
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM   80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6202811
MDR Text Key63264613
Report Number9611109-2016-00884
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Remedial Action Notification
Type of Report Initial,Followup
Report Date 09/05/2017
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 Number16-02-85
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/28/2016
Initial Date FDA Received12/23/2016
Supplement Dates Manufacturer Received12/05/2016
Supplement Dates FDA Received09/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2015
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
Patient Sequence Number1
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