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

Model Number 809810

Device Problem Low impedance (2285)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00613.Per the fsr, this unit continues to fail the ground leakage test at >1200 microamps in reverse polarity mode.This unit is owned and serviced by a third party, specialty care.The fsr advised the specialty care technical service manager of the situation and advised him not to use the unit.The fsr left a voicemail with the user facility perfusionist (ccp) advising her of the issue and recommended the unit not to be used until serviced by specialty care.Per the fsr, this heater cooler unit does not operate within manufacturer specifications and should not be used until the ground leakage issue is resolved.On 23-aug-2016, the speciality care service technician called the fsr asking if heating elements were available from the manufacturer.

Event Description

The field service representative (fsr) reported that during the notice of field correction (nfc) of the device, the heater cooler unit failed leakage current test at >1200 micro amps in reverse polarity mode (limit is <100).Unit passed in normal polarity at 84 micro amps.This is a back-up unit.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Per follow up with the specialty care technical service manager, they replaced the heating element to resolve the problem.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: 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: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 5942800
• MDR Text Key: 54801570
• Report Number: 1828100-2016-00612
• 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: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• 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: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2009
• 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