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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/13/2012

Event Type  Injury  

Manufacturer Narrative

The hospital has four units for which the serial numbers were provided in the user medwatch report.The specific unit used for this patient is unknown.The four serial numbers are: (b)(4).Manufacture dates: (b)(4): 11/19/2010, (b)(4): 11/19/2010, (b)(4): 11/19/2010, (b)(4): 12/21/2011.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 iowa city, ia.This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a user medwatch report on april 28.2016, stating that a patient underwent cardiac surgery four years ago to remove a left ventricular assist device to reduce sternotomy.This procedure involved the use of a sorin heater-cooler system 3t, and blood culture results from the patient are now indicating potential mycobacterium avium complex.Follow-up communication with the customer revealed that the units were originally placed inside the or and were briefly quarantined and samples were taken.The facility has since returned the units to service outside the or.The results of samples taken from each of the four units came back positive for mycobacterium chimaera.The facility reported that disinfection has always been performed according to ifu.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 on (b)(6) 2016, stating that a patient underwent cardiac surgery four years ago to remove a left ventricular assist device to reduce sternotomy.This procedure involved the use of a sorin heater-cooler system 3t, and blood culture results from the patient are now indicating potential mycobacterium avium complex.

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Several attempts were made to obtain additional information regarding the contamination status of the devices in use at the facility.However, no further information has been provided.It is unlikely that more information will be provided due to on-going litigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Corrective actions are in progress for this issue.

• 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: 5686759
• MDR Text Key: 46161818
• Report Number: 9611109-2016-00283
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• 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?: No
• Date Manufacturer Received: 08/18/2016
• 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: 61 YR