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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 Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
An exact event date was not provided. The user report stated that the surgery occurred in 2014, and the positive results were received in 2016. This information will be provided in a supplemental report if and when made available. Sorin group (b)(4) manufactures the sorin heater-cooler system 3t. It is unknown where this incident occurred. This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a user medwatch report (mw5062526) stating that a mycobacterium avium-intracellulare was identified in blood, urine and bone marrow cultures from a patient who had undergone an open heart surgery procedure in 2014 involving a sorin heater-cooler system 3t. The cultures were taken in 2016. The facility reports that they are unable to confirm the source of the infection. As no device information or contact information for the facility or for the initial reporter was provided in the user medwatch report, sorin group (b)(4) is unable to perform any follow-up with the customer regarding this event at this time. Additional information was requested from fda on july 25, 2016 regarding this user report. On july 27, 2016, (b)(6) with the fda responded that any missing or redacted information was removed at the request of the submitter, and no new information would be provided. Sorin group was asked to perform due diligence and ensure that there is no additional information regarding this event contained in an already existing complaint. A review of existing complaints did not identify any event that matched the description provided in the user report. No further investigation is possible.
 
Event Description
Sorin group (b)(4) received a user medwatch report (mw5062526) stating that a mycobacterium avium-intracellulare was identified in blood, urine and bone marrow cultures from a patient who had undergone an open heart surgery procedure in 2014 involving a sorin heater-cooler system 3t. The cultures were taken in 2016. The facility reports that they are unable to confirm the source of the infection.
 
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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
lindbergstr. 25
munich, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5828178
MDR Text Key50612618
Report Number9611109-2016-00441
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial
Report Date 06/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/27/2016 Patient Sequence Number: 1
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