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

Model Number 809810

Device Problem Insufficient Heating (1287)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the heater-cooler displayed an "e08" error message on channel a.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the heater-cooler had an incident during a cpb procedure with the patient cooling/warming side.The heater-cooler was set up and worked for the early part of the cpb procedure on (b)(6) 2018.During rewarming of the patient, the perfusionist had the heater-cooler give an "e08" error message on the patient side channel.The perfusionist had to the exchange the unit out, for he was unable to warm the patient with the e08 failure.The perfusionist proceeded accordingly with the working unit.The incident did not delay the surgical procedure, for the perfusionist was able to exchange the unit in a timely manner to give the surgical team time to perform the repair.There was no blood loss or harm associated with the event.

Manufacturer Narrative

The field service representative (fsr) verified the reported complaint.He replaced the heater assembly on channel a.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) measured the resistance of the heater elements and found the heater element supplied by the blue wires to be open.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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7903393
• MDR Text Key: 122155643
• Report Number: 1828100-2018-00492
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K071521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1