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

Model Number 816571

Device Problem Output Problem (3005)

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

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the pump was giving underspeed and belt slip alarms.He replaced the pump.The unit operated to the manufacturer's specifications.The unit will be sent back 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 pump displayed an 'underspeed' alarm.No other details regarding the nature of this event were provided.

Event Description

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

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2019, large roller pump reported many 'underspeed (head < demand)' and two 'underspeed (belt slip)' events as reported.The log confirms the complaint.During laboratory analysis, the product surveillance technician (pst) observed that the large roller pump did not perform according to product specifications.He observed multiple underspeed events.He replaced the motor/encoder assembly with a lab use only motor/encoder assembly and the issue was resolved, determining that the customer's motor/encoder assembly was defective.Washers were also found to be missing from the motor assembly.The service repair technician (srt) also found that the pin for the motor encoder cable assembly was pushed out of the connector.The motor/encoder assembly was replaced.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: 9252959
• MDR Text Key: 168848873
• Report Number: 1828100-2019-00567
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)181120
• 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: 03/30/2020

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/29/2019; 02/03/2020; 03/27/2020
• Supplement Dates FDA Received: 11/19/2019; 02/26/2020; 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1