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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 16-02-82
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Bacterial Infection (1735)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative

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 involved heater-cooler has been sequesetered. However, the device is still available for use in emergency cases. The customer stated that the cleaning protocols have been followed and the unit was used within the or during procedures. The contact stated that the unit has not and will not be tested for contamination. The customer reported that the patient is currently undergoing care for the infection, which the facility anticipates will need to be continued for approximately 1 year. On december 29, 2016, sorin group (b)(4) received a loaner request from the facility for the involved device, stating that the unit has been sequestered in compliance with governing entities due to non-tuberculous mycabacteria (ntm) contamination. During follow-up communication with the submitter of the loaner request, it was stated that the unit has been tested. However, additional follow-up communication with the customer confirmed that the device has not been tested for contamination. 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

Sorin group (b)(4) received a report that cultures from a patient who underwent a surgery in 2015 tested positive for mycobacterium chimaera. The surgery involved the use of a sorin heater-cooler system 3t. The report stated that the device has not been cultured. On december 29, 2016, sorin group (b)(4) received a user medwatch report (mw5066656) related to this patient. The report stated that the patient had a 92-minute-long open heart surgery in 2015 and developed a mediastinal abscess in 2016. The patient was brought in for surgery to remove the wires and the abscess. Bacterial cultures identified mycobacterium chimaera in the chest wound.

 
Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). Through further follow-up communication, it was stated that no further information will be released from the facility. Therefore no further investigation is possible. Livanova (b)(4) has initiated a capa ((b)(4)) for this type of issue. Device remains at customer site.

 
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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,
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, germany 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6251867
MDR Text Key64885092
Report Number9611109-2016-00954
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 09/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-82
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/13/2012
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 TREATMENT DATA
Date Received: 01/13/2017 Patient Sequence Number: 1
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