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 Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's technical support specialist, at first, the system booted up normally.Once it was rebooted and every time thereafter, the error message was displayed.The field service representative (fsr) verified the disk boot failure.He replaced the coin cell battery, which resolved the issue.The hard drive was due to be replaced in six months.The fsr spoke with the facility's biomedical engineer and it was decided to replace the hard drive as a courtesy and a precaution.All release testing was performed.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed a 'disk boot failure.Insert system disk and press enter' message.As a result, an alternate device was employed.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.The product surveillance technician (pst) observed the coin battery to be received with 0.375 volts direct current (vdc).The battery did not have enough voltage to supply power to the basic input output system.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Additional information received: the surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• 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
• MDR Report Key: 11148682
• MDR Text Key: 226091079
• Report Number: 1828100-2021-00015
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1