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

Model Number 802018

Device Problem Sensing Intermittently (1558)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the flow module was intermittently not getting flow readings.The flow module was unplugged and plugged back in and worked correctly.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per the user facility, the reported complaint happened once during set-up of the device and once during use of the device for a cardiopulmonary bypass (cpb) procedure.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) verified the reported complaint.He reseated all of the flow module and flow sensor connections resolving the problem.The unit operated to the manufacturer's specifications.Per data log analysis, the complaint was made on (b)(6) 2018, but the flow log only covers (b)(6) 2018.There was no indication of a problem with the flow meter in the system log.The log cannot be used to confirm the complaint.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Per clinical review: the perfusion team had an incident with their flow module on an heart lung machine (hlm) during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2018.During set up the team lost the flow readings for the blood flow generated from the centrifugal pump, they reattached the flow module to the network interface card (nic) board and proceeded without issue.The team then had one additional occurrence of loss of flow reading during the bypass procedure, and the team again just adjusted the plug to the nic board and the issue was mitigated for the remaining portion of the procedure.The intermittent loss in flow reading did not delay the surgical procedure.There was no blood loss or harm associated with the occurrence.

• 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: 8114981
• MDR Text Key: 129065884
• Report Number: 1828100-2018-00610
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)180419
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1