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

Model Number 801041

Device Problem Increased Pump Speed (1501)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the sucker pump ramped up to a high speed with no input from the perfusionist.The pump was restarted and the issue was resolved.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the pump was set up without issue with a quarter inch polyvinyl chloride (pvc) tubing, and the occlusion was set accordingly for the procedure on (b)(6) 2019.Once on bypass, the team turned on the pump from the central control monitor (ccm) icon.The roller pump went to max speed, without input on the slider from the user.He automatically turned the pump off, and then tried to turn it back on with the ccm and was able to appropriately increase the speed with the slider.The team was able to use the roller pump without issue the remainder of the case.This occurrence only happened once during the procedure.They have used the roller pump since without issue.There was no harm or blood loss associated with the event.This over-speed event did not delay the continuation of the surgical procedure.

Manufacturer Narrative

The field service representative (fsr) performed preventive maintenance (pm) on 30-sep-2019 and observed the unit operated to the manufacturer's specifications.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.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: 8944533
• MDR Text Key: 159864003
• Report Number: 1828100-2019-00464
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1