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

Model Number 816572

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the controller for the arterial centrifugal lost power.The unit was restarted and powered back on.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint.The centrifugal controller ran continuously for 24 hours with no observation of the drive motor stopping or any loss of power.The unit functioned as intended throughout the evaluation.

Manufacturer Narrative

The suspected device was returned to the manufacturer for further evaluation.

Manufacturer Narrative

The field service representative was unable to duplicate the reported complaint.He installed a spare centrifugal controller.The unit operated to the manufacturer's specifications.The suspect unit will be sent back to the manufacturer for further evaluation.

Manufacturer Narrative

Updated block: h6.The reported complaint could not be confirmed.The service repair technician was unable to verify the reported issue.The unit operated to the manufacturer's specifications.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: 10125791
• MDR Text Key: 199087591
• Report Number: 1828100-2020-00210
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)180628
• 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,Followup,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816572
• Device Catalogue Number: 816572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1