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 Display or Visual Feedback Problem (1184); Failure to Power Up (1476)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Per the subsidiary, the roller pumps were able to be started but it was not possible to program the pumps to obtain the desired flows for the patient without the ccm booting up.

Event Description

It was reported that the central control monitor (ccm) would not turn on.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was not verifiable.Multiple diligence attempts for part return and additional information were unsuccessful so an evaluation could not be completed.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 was received that the reported issue occurred during priming of the device for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.There was a five minute delay to change out the batteries.There was no blood loss nor adverse consequences to the patient.

Manufacturer Narrative

Per the subsidiary, when the heart lung machine (hlm) was disconnected from alternating current (a/c) power it shut down.The user facility installed new batteries that were from another manufacturer.After reconnecting the hlm, the unit was able to be used for the surgical procedure.

• 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: 11065768
• MDR Text Key: 225728789
• Report Number: 1828100-2020-00500
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K151349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1