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

Model Number 16-02-85

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Bacterial Infection (1735); Cellulitis (1768)

Event Date 06/03/2016

Event Type  Injury  

Manufacturer Narrative

A serial number was not provided in the user medwatch report.However, a sorin group field service representative was asked by the facility ((b)(6) hospital) to evaluate two of the 8 heater-cooler units currently at the facility ((b)(4)) in relation to patient infections.It is unknown which unit was used for this patient.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).(b)(4).Sorin group (b)(4) received a user medwatch report (mw5063487) on july 29, 2016, which stated that cultures taken from a patient tested positive for mycobacterium fortuitum after undergoing a procedure (aortic ascending aneurysm repair) in 2016 that involved a sorin heater-cooler system 3t.The patient was discharged, but was later readmitted to the hospital for sternal incision cellulitis with retrosternal fluid collection.The patient was discharged from the hospital a second time, but was readmitted again due to worsening sternal wound.The patient underwent an incision and drainage of a sternal wound, as well as debridement and muscle flap closure.The patient was discharged a third time, but was again readmitted to further treat the sternal wound infection.The patient returned to the operating room for debridement and irrigation of the sternum.The patient had been discharged from the hospital at the time that the user report was filed.The patient experienced multiple readmissions to the hospital and additional surgical operations as a result of the mycobacterium infection.The user report indicated that all mycobacterium cultures taken from the heater-cooler machine used on this patient have shown negative results.Cleaning records have been maintained and the machine that was used on this patient was pulled from use to undergo extensive testing and subsequent cleaning and disinfection.A sorin group field service representative was dispatched to the facility to investigate.The biomedical department had already lifted the patient and cardioplegia bridges on one heater-cooler system 3t ((b)(4)) and identified contaminants in the patient tank.The cardioplegia warm and cold tanks were clean.The service representative lifted the patient and cardioplegia bridges on the second unit ((b)(4)) and observed the same type of contaminants on the bottom of the patient tank.The cardioplegia warm and cold tanks were also clean for the second unit.The other units at the hospital were also inspected and no contamination was found in any of the tanks.Through follow-up communication with the customer, sorin group (b)(4) learned that both units ((b)(4)) have been tested, however the final result are not yet available.The customer stated that they are uncertain if the cleaning and disinfection procedure outlined in the operating instructions has always been followed.The two machines in question have been sequestered.The customer reported that the patient is currently under continuing care.A review of the dhrs for both units did not identify any deviations or non-conformities relevant to the reported issue.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 (mw5063487) on july 29, 2016, which stated that cultures taken from a patient tested positive for mycobacterium fortuitum after undergoing a procedure (aortic ascending aneurysm repair) in 2016 that involved a sorin heater-cooler system 3t.The patient was discharged, but was later readmitted to the hospital for sternal incision cellulitis with retrosternal fluid collection.The patient was discharged from the hospital a second time, but was readmitted again due to worsening sternal wound.The patient underwent an incision and drainage of a sternal wound, as well as debridement and muscle flap closure.The patient was discharged a third time, but was again readmitted to further treat the sternal wound infection.The patient returned to the operating room for debridement and irrigation of the sternum.The patient has been discharged from the hospital.The patient experienced multiple readmissions to the hospital and additional surgical operations as a result of the mycobacterium infection.The user report indicated that all mycobacterium cultures taken from the heater-cooler machine used on this patient have shown negative results.Cleaning records have been maintained and the machine that was used on this patient was pulled from use to undergo extensive testing and subsequent cleaning and disinfection.

• 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: 5902290
• MDR Text Key: 52939657
• Report Number: 9611109-2016-00537
• 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: Notification
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2015
• 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: 79 YR