MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. HX2 TEMPERATURE MANAGEMENT SYSTEM

Model Number 809810

Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the heater cooler unit tripped the line isolation monitor (lim) alarm.There was excess current leakage when running goes over two milli amps.As a result, an alternate device was employed.The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the patient.

Manufacturer Narrative

The customer took the heater cooler unit to another room to see if it would trip the lim in that room, and it did.Customer wants to make the repairs himself.In this case, the issue was corrected by the replacement of the heating element.The heating element is incased in a metal housing, which is secured to the chassis of the hx2 heater cooler.The chassis of the heater cooler is attached to earth ground through the power cord.In this case, the heater element is shorting to ground and is not a shock hazard.The element would eventually short out and trip the 15amp main circuit breaker on the unit.

• Brand Name: HX2 TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: HX2 TEMPERATURE MANAGEMENT SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3862874
• MDR Text Key: 18933841
• Report Number: 1828100-2014-00072
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 809810
• Device Catalogue Number: 809810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1