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

Model Number 809810

Device Problems Partial Blockage (1065); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, a "e0e" error code occurred on channel b of the heater cooler unit.The device was not changed out, as the customer reset the unit and finished the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00208.After the case, the heater cooler unit was pulled out of service.The field service rep (fsr) verified the unit was receiving a fault code of "e0e" on channel b when the unit was heated to 42 degrees celsius and into a cool-down.During testing, the fsr found mix valve failing, causing the e0e error.The customer has very poor quality water scale from the ice maker, which leaves a sandy residue in the ice/water tank.The fsr suspects the residue is clogging the mix valves causing them to fail.The fsr flushed clean water through the unit many times and the customer has tried descaling the unit but neither have resolved the issue.The mix valves are on back-order at this time.The fsr is awaiting repair parts.The fsr removed the unit from service.

Manufacturer Narrative

The reported complaint was confirmed.No add'l action will be taken at this time.

• 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: 4620425
• MDR Text Key: 5653417
• Report Number: 1828100-2015-00209
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• 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: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-07/30/15-001-C
• Patient Sequence Number: 1