MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AHCT

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per customer, the unit passed all tests at start-up.

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, there was an electrical burning smell coming from the device.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: prior to going on bypass on (b)(6) 2017 the perfusionist on the case smelled what he considered an obvious electric smell.It was coming from the area of the heart lung machine (hlm) and blood parameter monitoring (bpm) system.Their bpm is plugged into the back of the hlm.Perfusion contacted their biomedical department, and they rolled the hlm out into the hallway.Once the set up was in the hallway, they deduced that the electrical burning smell was coming from the bpm.There was no smoke, nor flames, and the bpm unit was not hot.The units outer housing was not physically damaged.There was no delay in the surgery, the team used another hlm with another bpm.The patient had no harm, nor blood loss, and the surgical procedure was performed without concern.

Manufacturer Narrative

(b)(4).During laboratory analysis, the product surveillance technician (pst) observed component c25 on the aux board assembly failed (burned) and was found to be the cause of smoke.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) replaced the auxiliary (aux) printed circuit board assembly (pcba).The unit operated to 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.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7067036
• MDR Text Key: 94242241
• Report Number: 1828100-2017-00535
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• 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,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 02/08/2018
• Supplement Dates FDA Received: 12/21/2017; 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2006
• 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