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

Model Number 809810

Device Problems Insufficient Heating (1287); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) was unable to verify that channel a cannot reach 38 degrees.However, while heating with both channels, he did verify that channel a was lagging compared to channel b.In addition, once channel a reached the temperature it would continue to decrease and increase to try to maintain temperature.Mix valve assembly was replaced.Unit performed to and meets manufacturer's 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

It was reported that during use of the device for a cardiopulmonary bypass procedure (cpb), the heater cooler (hx2) would not see past 32 degrees on the patient side.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 on 03-feb-2017: the certified clinical perfusionist (ccp) reported that during rewarming of the patient, the output water temperature of the hx2 side that was being delivered to the oxygenator was not able to be rewarmed above 32 degrees c.The ccp re-booted the hx2 in attempt to be able to warm the water to 37-38 c, but after re-boot, the outlet water temperature did not warm again above 32 c.There were no error codes posted.The perfusionist had a back-up hx2 available and they elected to use the back-up to complete the rewarming process.The change out did not delay the procedure.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) rotated the valve by hand and it rotated smoothly.He disassembled the valve assembly and measured the outside diameter of the valve shaft which measured 0.620 inches which is within the specification of 0.623, +0/-0.003 inches.He then measured the outside diameter of the valve shaft o-ring and it measured 0.650 inches which is outside the specification of 0.625 inches.However, the measurement was taken after the o-ring had been installed into the valve assemble and does not take into account any design interference/distortion that may occur after installation; and is not a valid comparison.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: 6350706
• MDR Text Key: 68281486
• Report Number: 1828100-2017-00092
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

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: Health Professional
• Device Model Number: 809810
• Device Catalogue Number: 809810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2008
• 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