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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN HEATER COOLER UNIT

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SORIN HEATER COOLER UNIT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Fever (1858); Hemorrhage/Bleeding (1888); Pneumonia (2011); Septic Shock (2068); Urinary Tract Infection (2120); Impaired Healing (2378); Respiratory Failure (2484); Bowel Perforation (2668)
Event Date 01/01/2015
Event Type  Death  
Event Description
Patient chronically and progressively ill with cardiomyopathy. Underwent hearmate ii lvad placement on (b)(6) 2014. Remained hospitalized after that until time of death on (b)(6) 2015. He had numerous hospital complications including vdrf, failure to thrive, gi bleeds, pneumonia, uti, bowel perforation with septic shock and bacteremia, renal failure requiring dialysis. On (b)(6) developed fever and septic shock. Blood cultures eventually identified as m. Abscessus. Patient died of progressive shcol on (b)(6). Because of (b)(6) 2014 lvad placement, patient was on bypass with sorin heater cooler unit in operating room.
 
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Brand NameHEATER COOLER UNIT
Type of DeviceHEATER COOLER UNIT
Manufacturer (Section D)
SORIN
MDR Report Key5382509
MDR Text Key36534616
Report NumberMW5059467
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/15/2016 Patient Sequence Number: 1
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