• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 09/07/2016
Event Type  Death  
Manufacturer Narrative
Patient information was not provided. The date of death was not provided. This information will be submitted in a supplemental report if and when made available. The date of event was not provided. This information will be submitted in a supplemental report if and when made available. The model and serial number were not documented in the report, and the unique identifier (udi) number could not be determined. This information will be provided in a supplemental report if and when made available. As the serial number was not provided, the device manufacture date could not be determined. This information will be provided in a supplemental report if and when made available. Sorin group (b)(4) manufactures the sorin heater-cooler system 3t. The incident occurred in (b)(6). (b)(4). The customer was contacted regarding this event to get additional information about the patient and any involved device(s). However, the risk manager contacted was unaware of the event and no additional information could be provided. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
During a literature conducted on december 19, 2016, an article from philadelphia inquirer (http://www. Philly. Com/philly/blogs/healthcare/two-more-infections-tied-to-heart-surgery-device-tri-state-total-at-24. Html) was identified which mentions a heart-surgery patient in the philadelphia area has tested positive for a worrisome, slow-growing bacteria that has been linked to a device called a heater-cooler. The article alleged that a sorin heater-cooler system 3t was used during the procedure. The patient has died, though hospital officials have stated that it is not yet clear what role the bacteria may have played in the death.
 
Manufacturer Narrative
Date of death (mm/dd/yyyy): (b)(6) 2016. Date of event (mm/dd/yyyy): (b)(6) 2016. Through follow-up communication with the customer, (b)(4) learned that the facility is unable to identify which unit in use at the facility was utilized during the patient's surgery. The customer reported that all units have been removed from service and cultures have been collected. The test results were not available at that time. Additional information about the patient was also provided. The patient was reportedly admitted to the hospital on (b)(6) 2015 for a cabg and valve replacement surgery. The patient was discharged on (b)(6) 2015. On (b)(6) 2016, the patient complained of six weeks of fever, night sweats and malaise. The patient was diagnosed with endocarditis and non-tuberculous mycobacterium was identified in the patient on (b)(6) 2016. The patient died on (b)(6) 2016. The investigation is on-going. If any additional information pertinent to the reported event is received , it will be provided in a supplemental report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6262495
MDR Text Key65201798
Report Number9611109-2016-00961
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/18/2017 Patient Sequence Number: 1
-
-