MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULAR PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM

Model Number 16422

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The srt found that during preventative maintenance (pm) of the device, the universal power supply board (upsb) was defective.The trimmer potentiometer adjustment screw on the ups battery module board would not adjust the charging voltage.It was spinning without making any charging voltage adjustments.The upsb board was replaced.The unit operated to the manufacturer's specifications.

Event Description

The service repair technician (srt) reported that during testing of the device at the service center, the universal power supply (ups) battery module board was defective.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.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: SARNS 8000 MODULAR PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11049704
• MDR Text Key: 223185650
• Report Number: 1828100-2020-00487
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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: 16422
• Device Catalogue Number: 16422
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1