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 850019

Device Problem Electrical Overstress (2924)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

The srt replaced the aux pcba board.The unit operated to the manufacturer's specifications.The suspect device was sent to the laboratory for further evaluation.

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the capacitor at location c132 on the auxiliary (aux) printed circuit board assembly (pcba) had blown up when the unit was powered up.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the cap at location c132 to be blown.

Manufacturer Narrative

The reported complaint was confirmed.Per the suppliers evaluation, the damaged capacitor was removed but a short was still present on the line.Upon further review it was found that the transistor at location q10 was also damaged.Specifically, pins three and four of the q10 transistor were internally shorted.This was verified by taking measurements after de-soldering and lifting the legs of the transistor.The damaged transistor at q10 led to the damage of the c132 capacitor.The transistor at q10 was damaged due to electrical overstress, such as a surge in current, which then led to the failure and damage of the capacitor at c132.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
• MDR Report Key: 8422150
• MDR Text Key: 138948904
• Report Number: 1828100-2019-00128
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2019

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: Other
• Device Model Number: 850019
• Device Catalogue Number: 850019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/08/2019; 06/14/2019
• Supplement Dates FDA Received: 04/29/2019; 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1