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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/01/2014

Event Type  Death  

Manufacturer Narrative

Patient age and weight were not provided.Exact event date (date patient diagnosed with infection) is unknown.Patient underwent surgery on (b)(6) 2014 and was diagnosed with infection approximately 4 to 6 weeks later.The model and serial number have not been provided and the udi could not be determined.This information will be provided in a supplemental report if and when made available.The serial number was not provided, so it is unknown if the unit has already been returned or not.This information will be provided in a supplemental report if and when made available.The serial number was not provided, so the 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).This medwatch report is being filed on behalf of sorin group (b)(4).On july 8, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on june 28, 2016.After receiving and reviewing the legal complaint against our complaints records, it is our belief, based on the current information provided to date, that the legal complaint identified one of the 15 patients who was reportedly infected with mycobacterium at (b)(6) hospital (see medwatch report 1718850-2014-00398 for original report).The patient tested positive for a mycobacterium abscessus sternal wound infection approximately 4 to 6 weeks after undergoing a coronary artery bypass grafting procedure on (b)(6) 2014 involving a sorin heater-cooler system 3t.The patient expired on (b)(6) 2014.Risk management and legal representatives from the facility have confirmed that an independent engineering expert engaged by the hospital has excluded the sorin heater-cooler device as a contributing factor.Risk management noted that the engineer ran dye through the device and found no leakage, concluding that no bacteria could leak from the device.Furthermore, public statements released by the facility on july 26, 2014, indicate "officials have linked the infection, mycobacterium abscessus, to tap water at (b)(6) hospital", and that it is "unlikely that the equipment allowed tap water to contact patients." sorin has previously contacted the facility and inquired if the equipment was available for return sorin group (b)(4) for further evaluation.No request has been made by the facility.

Event Description

On july 8, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on june 28, 2016.After receiving and reviewing the legal complaint against our complaints records, it is our belief, based on the current information provided to date, that the legal complaint identified one of the 15 patients who was reportedly infected with mycobacterium at (b)(6) hospital (see medwatch report 1718850-2014-00398 for original report).The patient tested positive for a mycobacterium abscessus sternal wound infection approximately 4 to 6 weeks after undergoing a coronary artery bypass grafting procedure on (b)(6) 2014 involving a sorin heater-cooler system 3t.The patient expired on (b)(6) 2014.

• 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): SORIN GROUP DEUTSCHLAND; lindbergstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5873527
• MDR Text Key: 52056424
• Report Number: 9611109-2016-00563
• 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: other
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• 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
• Date Manufacturer Received: 07/08/2016
• 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