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

Model Number 500AVHCT

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the screen of the cdi 500 blood parameter monitor was dead, the screen went black, and they noticed a burning electrical smell.The device was shut down.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: during cpb, the cdi 500 display totally blanked (loss of display) and a burning smell was observed.The monitor was powered-down and not used for the remainder of the procedure.A back-up unit was brought in for the remainder of the case.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) found blood parameter monitor failed to boot up properly, the screen was black and single board computer (sbc) printed circuit board assembly (pcba) was beeping, there was a smell of burnt/blown electrical components.The hematocrit saturation module (h/sat) servo card was found to be defective, it had a shorted and blown out component (c11) close by components of u11 and u4 possibly affected as well.This component (c11) being shorted caused the +12v & -12v direct current (d/c) of the system voltage too drop to around +5, and -7.99v dc, producing the blank screen on startup, beeping of the sbc pcba.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 service repair technician (srt) installed a new hematocrit saturation module (h/sat) servo card on monitor and it successfully passed startup self test to manufacturer's specifications with no errors.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

(b)(4).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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6130348
• MDR Text Key: 61233921
• Report Number: 1828100-2016-00765
• 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,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2012
• 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