MAUDE Adverse Event Report: SORIN HEATER COOLER UNIT

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.

• Brand Name: HEATER COOLER UNIT
• Type of Device: HEATER COOLER UNIT
• Manufacturer (Section D): SORIN
• MDR Report Key: 5382509
• MDR Text Key: 36534616
• Report Number: MW5059467
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 105