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 Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventative maintenance (pm) of the device, after replacing the coin cell battery, the central control monitor (ccm) monitor would not come on.There was no patient involvement.

Manufacturer Narrative

Per the fsr, the unit had not been used for a year.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the central control monitor (ccm) to initially not boot up at all.The coin cell battery was removed and the ccm booted up with a 'disk boot failure' message as expected.The coin cell battery voltage was measured to be approximately 2.7 volts (v) while a normal battery is 3v.A lab use only (luo) coin cell battery was installed and the ccm booted without any issues.The service repair technician (srt) reset the basic input output system (bios) and the unit passed release testing.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

The reported complaint was confirmed.Review of service history showed that the coin cell battery was not replaced in a timely manner for maintenance.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: 18188201
• MDR Text Key: 328971565
• Report Number: 1828100-2023-00357
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2024

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: Other
• Device Model Number: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/08/2023; 01/25/2024
• Supplement Dates FDA Received: 12/22/2023; 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• 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