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

Model Number 164267

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) could not verify the reported problem.He replaced the drive motor and downloaded logs.The unit operated to the manufacturer's specification.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during setup of the device for a cardiopulmonary (cpb) procedure, the pump was displaying a 'service pump' alarm.As a result, an alternate device was employed.There was no delay.No other details regarding the nature of this event were provided.

Event Description

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

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician was unable to duplicate the reported issue.The unit operated to the manufacturer's specifications throughout the evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Per data log analysis, on 28-oct-2019 the perfusion screen was opened twice and the centrifugal pump art was used both times.There were no indications in the log of any internal triggers that would have caused a 'service pump' alarm as reported.The pump itself did not report any internal alarms.The log does not confirm the complaint.During laboratory analysis, the product surveillance technician observed the centrifugal drive motor to perform as intended throughout the evaluation reporting no errors or malfunctions.

• 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: 9357653
• MDR Text Key: 199110451
• Report Number: 1828100-2019-00617
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000458
• UDI-Public: (01)00886799000458(11)180614
• 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
• Report Date: 06/09/2020

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: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 04/20/2020; 05/29/2020
• Supplement Dates FDA Received: 12/22/2019; 05/11/2020; 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1