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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Renal Failure (2041)
Event Date 06/18/2014
Event Type  Injury  
Manufacturer Narrative

The customer reported that the model and serial number are unknown. The unique identifier (udi) number could not be determined. As the serial number is unknown, the device manufacture date could not be determined. 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). Through follow-up communication with the customer, sorin group (b)(4) learned that the patient is still undergoing care. The customer stated that the details of the heater-cooler used at the time of the patient's surgery are unknown, and that all heater-coolers at the facility have been removed from service. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.

 
Event Description

On (b)(6) 2016, sorin group (b)(4) received a user medwatch report ((b)(4)) that two acid-fast bacillus (afb) blood cultures from a patient tested positive. The patient underwent a thoracic aorta repair with aortic valve replacement in 2014. The patient was admitted to the hospital in 2016 for 3 weeks following onset of illness and night sweats, weight loss, renal injury, mild transaminitis, splenomegaly, bilateral choroiditis, leukopenia and anemia. A liver biopsy reportedly revealed acute (b)(6) with granulomas. The patient was then readmitted for worsening renal function and a renal biopsy reportedly appeared to be consistent with acute interstitial nephritis (ain). The report states that the cause of the complications is a disseminated nontuberculous mycobacteria (ntm) infection. The facility suspects mycobacterium chimaera, and the patient was started on therapy 3 days after admission.

 
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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
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6265432
MDR Text Key65343913
Report Number9611109-2016-00969
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
Remedial Action Other
Type of Report Initial
Report Date 01/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
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: 01/19/2017 Patient Sequence Number: 1
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