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

Model Number 801188

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified that the flow readings were displaying differently between the central control monitor (ccm) and the external flow meter.A crack in the gas line at the connection of the external gas hose was found.The crack was causing a leak that was affecting the flow at the external flow meter.The fsr cut off the damaged section of the hose and reconnected, which corrected the flow readings.Release testing was performed.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the heart lung machine (hlm) was showing different gas flow readings than the manual flow meter.The perfusionist restarted the machine, but there was no change.As a result, an alternate device was employed.A pole mounted flow meter was utilized to determine the flow.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.Pictures were provided that showed the tubing involved in the reported complaint was from another manufacturer and had been leaking.There was no malfunction of the electronic patient gas system that was reported in this complaint.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: 10743634
• MDR Text Key: 213502540
• Report Number: 1828100-2020-00410
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)121211
• 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
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTERNAL FLOW METER; EXTERNAL FLOW METER