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

Model Number 809810

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the heater cooler unit leaks.The fsr found that the connection (pvc) that comes out of the tank was buckled.It was flat now rather than rounded and is on the "a-side".Since the event occurred during preventative maintenance, there was no patient involvement.

Manufacturer Narrative

The heater cooler unit initially had no water in it, as it hasn't been used for some time.The field service representative (fsr) put water in the unit and observed the reverse leakage current was at 145, unusually high.The fsr could not get a good seal on the hose clamp for the leak.Per technical support, the whole water tank would need to be replaced.This is spare unit for the customer.The fsr will send the customer's a quote for the repair.

• 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: 3987566
• MDR Text Key: 4636446
• Report Number: 1828100-2014-00469
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 809810
• Device Catalogue Number: 809810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2008
• 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