MAUDE Adverse Event Report: TERUMO TERUMO HX2 HEATER COOLER

Model Number	HX2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/06/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Developed mycobacterium abscessus (pericardial) and mycobacterium avium intracellulare (pericardial and abdominal abscess associated with drive line) infection 2.7 yrs following placement of a heartmate ii left ventricular assist device on (b)(6) 2012 as destination therapy for non-ischemic cardiomyopathy.Lvad placement performed with cardiopulmonary bypass using terumo hx2 heater cooler unit.Event is being reported per the request of pennsylvania department of public health.No evidence links the lvad surgery to the subsequent infection event.Had developed subcostal swelling below right rib cage in (b)(6) 2015 along the lvad drive line site.

• Brand Name: TERUMO HX2 HEATER COOLER
• Common Device Name: HX2 HEATER COOLER
• Manufacturer (Section D): TERUMO
• MDR Report Key: 5367762
• Report Number: MW5059336
• Device Sequence Number: 14015908
• Product Code: DWC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX2
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR