MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 816300

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the central control monitor (ccm) screen was blank.There were no reported consequences to the patient.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The field service representative (fsr) verified the reported complaint.The fsr replaced the ccm.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) connected the central control monitor (ccm) to lab use only (luo) testing equipment.The screen was successfully powered on for approximately 30 minutes before the monitor went black while the pst was attempting to return to the home screen while collecting data logs.The voltage (v) output from the single board computer (sbc) to the inverter was verified.A luo inverter was put into the ccm, which did power on for a brief duration before the backlight shut off, but the ccm did function.The monitor appeared not to function because there is no illumination of the display image.It was determined that the backlight of the ccm display did not meet specification.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: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18322749
• MDR Text Key: 330943799
• Report Number: 1828100-2023-00371
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001325
• UDI-Public: (01)00886799001325(11)201208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• 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