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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sepsis (2067)
Event Date 10/23/2014
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. 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 (b)(4) received a user medwatch report ((b)(4)) on march 21, 2016 which stated that a patient was admitted to the hospital for sepsis approximately 28 months after undergoing a coronary artery bypass graft procedure involving a sorin heater-cooler system 3t. Purulent drainage was noted at the sternal incision site. Cultures were taken, which tested positive for acid-fast bacilli. The wound required debridement and vac dressing placement. 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 march 21, 2016 which stated that a patient was admitted to the hospital for sepsis approximately 28 months after undergoing a coronary artery bypass graft procedure involving a sorin heater-cooler system 3t. Purulent drainage was noted at the sternal incision site. Cultures were taken, which tested positive for acid-fast bacilli. The wound required debridement and vac dressing placement.

 
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. 16s11491, 16s11887, 16s11927, 16s11941, 16s12286, 16s12474, 16s12475. Manufacturing dates: 16s11491: 10/31/2008, 16s11887: 11/12/2009, 16s11927: 12/17/2009, 16s11941: 01/20/2010, 16s12286: 09/14/2010, 16s12474: 01/18/2011, 16s12475: 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. Recall number: 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 received a user medwatch report (b)(4) on march 21, 2016 which stated that a patient was admitted to the hospital for sepsis approximately 28 months after undergoing a coronary artery bypass graft procedure involving a sorin heater-cooler system 3t. Purulent drainage was noted at the sternal incision site. Cultures were taken, which tested positive for acid-fast bacilli. The wound required debridement and vac dressing placement. 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 operating room. 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.

 
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Brand NameSORIN HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, 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 Key5585771
MDR Text Key42938659
Report Number9611109-2016-00203
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052601
Number of Events Reported1
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 Received04/18/2016
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2016
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 NumberZ-2076/2081-2015

Patient TREATMENT DATA
Date Received: 04/18/2016 Patient Sequence Number: 1
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