MAUDE Adverse Event Report: SORIN GROUPDEUTSCHLAND STOCKET HEATER-COLLER SYSTEM 3T; CONTROLLER, TEMPERATUR, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Sorin group received a notification of a user report that fifteen patient's presented with post-operative wound infection by an atypical mycobacterium.It was stated that the investigation is still on-going at the facility and the exact etiology is unknown.It was also reported that four of the patients had expired.Although the infections were thought to be a contributing factor, all patients had major underlying existing and significant medical conditions.This report is being filed as the user report indicated that the heater cooler equipment was "one common factor" in the relevant cases.In public statements released by the facility, the facility notes that it has obtained an independent analysis that concluded that it was "unlikely that the equipment allowed tap water to contact patients.".

Manufacturer Narrative

Sorin group (b)(4) manufactures the stockert heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a notification of a user repot that fifteen patients presented with post-operative wound infection by an atypical mycobacterium.It was stated that the investigation is still on-going at the facility and the exact etiology is unknown.It was also reported that four of the patients had expired.Although the infections were thought to be contributing factor, all patients had major underlying existing and significant medical conditions.This report is being filed as the user report indicated that the heater cooler equipment was "one common factor" in the relevant cases.In public statements released by the facility, the facility notes that it has obtained an independent analysis that concluded that it was "unlikely that the equipment allowed tap water to contact patients." the sorin investigation is on-going.A follow-up report will be submitted when complete.

Manufacturer Narrative

Additional information: sorin group (b)(4) manufactures the stockert heater-cooler system 3t.The incident occurred in (b)(6).(b)(4).Sorin group received a notification of a user report that fifteen patients presented with post-operative wound infection by a atypical mycobacterium.It was also reported that four of the patients had expired.Although the infections were thought to be a contributing factor, all patients had major underlying existing and significant medical conditions.Risk management initially stated that the user report was submitted because the heater cooler equipment was "one common factor" in the relevant cases.However, the facility did not file a complaint with sorin group.The reporting facility has declined to return the device for evaluation.They will not provide written information regarding their investigation or their results due to legal issues involving the hospital.Risk management and legal representatives from the facility have confirmed that an independent engineering expert engaged by the hospital has excluded the sorin 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 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" (july 26).Most recently, sorin again contacted the facility and inquired if the equipment was now available and whether the hospital wished to return the equipment to sorin group (b)(4) for any further evaluation.The hospital again declined to return the equipment to sorin for evaluation.Given that the facility's independent expert determined that the device was not a contributor, that the investigation driven by the facility showed the bacteria originated via the tap water and that the facility does not want the device returned for evaluation, no further action is deemed necessary at this time.However, sorin did proactively send an informational letter to 3t customers on 08/01/2014 regarding the disinfection and cleaning of heater cooler units emphasizing the importance of proper maintenance and cleaning.A response form was sent back to sorin indicating that the (b)(6) facility did receive this information.

Manufacturer Narrative

On july 14, 2016, sorin group was notified of four legal complaints.It is our belief, based on the current information provided to date, that the legal complaints identify the details of four patients who were reportedly infected with mycobacteria at (b)(6).Originally, a single report was filed for all reported patient infections at greenville health hospital, as no information specific to each patient had been provided.As we now have specific information regarding four additional patients, four additional medwatch reports (9611109-2016-00563, 9611109-2016-00567, 9611109-2016-00568 and 9611109-2016-00569) will be filed.Please see those reports for additional details.The customer has been contacted on several occasions, however they have stated that they are unable to discuss this issue any further with sorin group.Because the facility is unwilling to disclose any new information, the details of any additional infected patients are not known at this time.

Manufacturer Narrative

Additional information: sorin implemented a field safety notice for disinfection and cleaning of sorin heater cooler devices.The z number is z-2076/2081-2015.

• Brand Name: STOCKET HEATER-COLLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATUR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUPDEUTSCHLAND; 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: 4216869
• MDR Text Key: 18729109
• Report Number: 1718850-2014-00398
• 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,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: No
• 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