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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP SORIN 3T; SORIN 3T HEATER COOLER DEVICE
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SORIN GROUP SORIN 3T; SORIN 3T HEATER COOLER DEVICE Back to Search Results
Device Problems Product Quality Problem (1506); Microbial Contamination of Device (2303)
Patient Problems Left Ventricular Failure (1948); Sweating (2444)
Event Date 01/10/2017
Event Type  Injury  
Event Description
Pt had cabg on (b)(6) 2017 with sorin 3t heater cooler device in use.Started seeking care from primary care provider in (b)(6) 2017 for night sweats, fatigue and back pain.Pt continued with symptoms of night sweats, chills, fatigue, back pain, blurry vision.Blood culture for afb collected on (b)(6) 2017.Afb positive in (b)(6) 2017.(b)(6) medical center notified of positive blood culture on (b)(6) 2017 from private physician.Pt admitted to hospital on (b)(6) 2017 for further testing to include add'l blood cultures, mri, ct, bone marrow biopsy and ophthalmology consult.Given pt history of cabg with exposure to heater cooler device, clinical symptoms, and positive afb lab, the pt is being treated as a probable case of mycobacterium chimaera.
 
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Brand Name
SORIN 3T
Type of Device
SORIN 3T HEATER COOLER DEVICE
Manufacturer (Section D)
SORIN GROUP
arvada CO 80004
MDR Report Key7013301
MDR Text Key91840688
Report Number7013301
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2017
Distributor Facility Aware Date10/24/2017
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer10/30/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/09/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age54 YR
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