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

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 10/30/2014

Event Type  Injury  

Manufacturer Narrative

There was no patient identifier provided.This information will be submitted in a supplemental report if and when made available.The weight of the patient was not provided.This information will be submitted in a supplemental report if and when made available.The part and serial number were not provided.This information will be submitted in a supplemental report if and when made available.Mfg date: as no serial number was provided, the manufacture date cannot be determined.This information will be submitted 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).Sorin group received a user medwatch report (b)(4) on (b)(6) 2016 which stated that a patient was admitted to the hospital for syncope, diarrhea and fever approximately 28 months after undergoing thoracic aortic dissection repair.The procedure involved a sorin heater-cooler system 3t.The patient was diagnosed with aortic root abscess and required a coronary artery bypass graft and removal of the original graft and placement of a homograft to the ascending aorta.Blood cultures were taken for testing and were found to be positive for mycobacterium avium-intracellulare.Follow-up communication with the customer revealed that the patient was treated for the infection and has been released from the hospital.The involved unit has been removed from service and quarantined and the facility has purchased new units.The facility reported to have been performing disinfection cycles.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a user medwatch report (b)(4) on (b)(6) 2016 which stated that a patient was admitted to the hospital for syncope, diarrhea and fever approximately 28 months after undergoing thoracic aortic dissection repair.The procedure involved a sorin heater-cooler system 3t.The patient was diagnosed with aortic root abscess and required a coronary artery bypass graft and removal of the original graft and placement of a homograft to the ascending aorta.Blood cultures were taken for testing and were found to be positive for mycobacterium avium-intracellulare.

Manufacturer Narrative

The hospital owned seven units at the time that this procedure was performed.The facility does not document the serial number of the machine used in a given procedure.(b)(4).Manufacturing dates: (b)(4): 10/31/2008, (b)(4): 11/12/2009, (b)(4): 12/17/2009, (b)(4): 01/20/2010, (b)(4): 09/14/2010, (b)(4): 01/18/2011, (b)(4): 01/18/2011.(b)(4).All seven units tested positive for mycobacterium (see medwatch reports 9611109-2015-00555 through 9611109-2015-00561).The units were documented in a user medwatch report (b)(4).At the time this user report was issued by the hospital, no mycobacterium surgical site infections in cardiovascular surgical patients had been identified.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).Sorin group (b)(4) received a user medwatch report (b)(4) on (b)(6) 2016 which stated that a patient was admitted to the hospital for sycope, diarrhea and fever approximately 28 months after undergoing thoracic aortic dissection repair.The procedure involved a sorin heater-cooler system 3t.The patient was diagnosed with aortic root abscess and required a coronary artery bypass graft and removal of the original graft and placement of a homograft to the ascending aorta.Blood cultures were taken for testing and were found to be positive for mycobacterium avium-intracellulare.The patient was treated for the infection and has been released from the hospital.Follow-up communication with the customer revealed that the units had been used within the o.R.The facility has reported that disinfection has always been performed according to the ifu, but they do not document the disinfections.The units have been replaced and are no longer in use.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As corrective action, fsca 9611109-06/03/15-002-c was released to remind our customers about the importance of adhering to the water management and disinfection procedure.Units were replaced by customer.

• 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; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5585768
• MDR Text Key: 42938636
• Report Number: 9611109-2016-00204
• 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: Risk Manager
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2016
• 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
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR