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 Problem Death (1802)

Event Date 04/17/2015

Event Type  Death  

Manufacturer Narrative

The model and serial number were not provided in the user 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).Through follow-up communication with the reporting facility, sorin group (b)(4) learned that the original cardiac bypass surgery was performed at the (b)(6) hospital in (b)(6) on (b)(6) 2015.The patient was admitted to the (b)(6) university on (b)(6) 2016, where a complicated washout/debridement of the mediastinal infection was performed.The patient died on (b)(6) 2016 at the age of (b)(6) years.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

On november 28, 2016, sorin group (b)(4) received a user medwatch report (mw5066126) stating that a patient presented with a non-tuberculous mycobacterium infection after undergoing cardiac bypass surgery a year prior at a different facility.The patient died from the complications of the infection.

Manufacturer Narrative

During a complaint review conducted on july 13, 2017, it was discovered that this issue has been previously reported by another facility ((b)(6), where the surgical procedure took place) on user medwatch report (b)(4) and on the manufacturer report 9611109-2016-00775.The details of the two reports have been combined and will be submitted under 9611109-2016-00775.This medwatch report number is void as a duplicate.

• 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 Key: 6202790
• MDR Text Key: 63236022
• Report Number: 9611109-2016-00887
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

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: 11/28/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: 07/13/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR
• Patient Weight: 115