MAUDE Adverse Event Report: TERUMO TERUMO HX2 HEATER COOLER

Model Number HX2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/06/2015

Event Type  Injury  

Event 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
• Type of Device: HX2 HEATER COOLER
• Manufacturer (Section D): TERUMO
• MDR Report Key: 5367762
• MDR Text Key: 36042964
• Report Number: MW5059336
• 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: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX2
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR