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

Model Number 816570

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

The fsr removed the roller pump.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the roller pump displayed an 'underspeed' error message.There was no patient involvement.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician verified the reported issue.During evaluation, when the pump speed was increased to three liters per min (l/min) an under speed error occurred.The pump was disassembled to examine the motor, encoder pulley, gut assembly, and race bearing.Grease was evident throughout the inside of the pump.Grease and debris interferes with encoder function causing an underspeed error.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: 10943164
• MDR Text Key: 219515940
• Report Number: 1828100-2020-00470
• Device Sequence Number: 1
• Product Code: DTQ
• 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
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 816570
• Device Catalogue Number: 816570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1