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

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.

• 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6262495
• MDR Text Key: 65201798
• Report Number: 9611109-2016-00961
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death