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

Model Number 809810

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported issue was verified by the fsr on site.The device failed electrical safety by the reverse ungrounded leakage went above 100 a to 189 a.The fsr troubleshot to the heater on the a channel and confirmed it was the source of the problem.The heater was replaced and reverse ungrounded leakage was 69 a.Unit was operating within manufacture specifications.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

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, heater cooler (hx2) failed electrical safety by the reverse ungrounded leakage going above 100 a to 189 a.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) the resistance was measured between the heater's ground connection and heating elements.Both the main heating element and the secondary heating element measured approximately 2 megohms, 30 megohms was expected.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6349382
• MDR Text Key: 68279738
• Report Number: 1828100-2017-00090
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2009
• 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