MAUDE Adverse Event Report: TERUMO HX2 HEATER COOLER

Model Number HX2

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 02/20/2013

Event Type  Injury  

Event Description

Developed empyema and bloodstream infection with mycobacterium abscessus 4 months after double lung transplantation with cardiopulmonary bypass (cpb) using terumo hx2 heater cooler.

• Brand Name: HX2 HEATER COOLER
• Type of Device: HX2 HEATER COOLER
• Manufacturer (Section D): TERUMO
• MDR Report Key: 5319933
• MDR Text Key: 34240393
• Report Number: MW5058676
• 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: 12/17/2015

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
• Device Model Number: HX2
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR