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

Model Number 801763

Device Problems Communication or Transmission Problem (2896); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the power manager board was replaced to resolve the issue.

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb)procedure, multiple pumps had connection failures with the heart lung machine (hlm) and displayed 'fail' messages.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per data log review, on 22-dec-2020, many of the pumps and modules were reporting '5 volt (v) supply voltage test failures'.This will cause an alarm tone to sound, failed indications on the main screen, and a red x on the pump and module icon as reported.The following are the pumps and modules that reported the 5v error.Some of the logs did not export properly so there were likely more that had the 5v issue.The log confirms the complaint, the likely cause is in the power cable from the power manager to the right network interface card (nic), the power manager, or the nic.During laboratory analysis, the product surveillance technician (pst) observed some significant buildup on the three fuses associated with the 5v line, removing and re-seating the fuses restored some of the original contact surface.The reported complaint was not reproduced during evaluation.

Manufacturer Narrative

H3: 81 evaluation is in progress but not yet concluded.

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: 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: 11149013
• MDR Text Key: 226101988
• Report Number: 1828100-2021-00017
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2021

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: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/27/2021; 02/23/2021; 04/13/2021
• Supplement Dates FDA Received: 02/18/2021; 03/17/2021; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1