MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. HX2 TEMPERATURE MANAGEMENT SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.

Model Number 809810

Device Problems Device Reprocessing Problem (1091); Device Contamination With Biological Material (2908); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is being submitted in response to u.S.Food and drug administration (fda) request.This complaint is related to emdr #1828100-2016-00326.The user facility¿s biomedical engineer (biomed) stated they perform semiannual preventative maintenance and electrical safety testing every six months.The operating room (o/r) staff performs the chlorine and cleaning maintenance.The biomed did not experience issues with cooling or heating and no leaks were observed.The reported complaint was confirmed.The field service representative (fsr) stated the customer have been cleaning the unit twice a day.The fsr reviewed the proper cleaning and de-scaling procedure with the perfusionist (ccp) and the biomed.The fsr walked through the steps in the cleaning guide and reviewed the required chemicals need to maintain the unit.The manufacturer provides established requirements for sanitization and instructions for correctly maintaining the system.These are clearly outlined in the operators manual and the hx2 temperature management system cleaning guide.Included in the requirements is a daily sanitization procedure with a check of the chlorine levels, weekly cleaning and sanitization and a semiannual descaling procedure.Decontamination is required whenever biofilm is evident in the system (discoloration or cloudiness in the water system).If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during the use of the device for a non-clinical activity, the heater cooler unit seemed to have a lot of algae.They clean the unit twice a day and it still seems to have this issue.There was no patient involvement.

• Brand Name: HX2 TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5649861
• MDR Text Key: 45199914
• Report Number: 1828100-2016-00327
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• 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?: No
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2009
• 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