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 Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Per field service representative (fsr) the epgs was testing within the manufacturer's specifications but the user facility's perfusionist thought the discrepancy was too high and wanted to the unit replaced.The fsr replaced the epgs.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) was reading 0.5 liters per minute (lpm) high.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the flow readings to be within 0.02 liter per minute (l/min) of the set point as read with the central control monitor (ccm) and an external flowmeter.

Event Description

Per clinical review: during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2018, the perfusionist on the case noticed that his sweep gas flow from the electronic patient gas system (epgs) was reading approximately.5 liters per minute (lpm) higher than expected.The perfusionist asked for the system to be looked at and exchanged with another epgs system, for his concern was that at 2.0 lpm a.5 difference was noticeable.The field service representative (fsr) tested the system and all specifications were within limits.It is not known if the perfusionist was concerned about the reading on the central control monitor (ccm) screen versus the set value of the gas flow, or if his concern was that the difference was between the reading on the ccm versus an external ball analog flow meter.The external ball meter did have an estimated flow, but the graduations between the liters of flow were at liters not milliliters.The epgs concern did not delay the continuation of the surgical procedure, and there was no harm or blood loss associated with the occurrence.

Manufacturer Narrative

Per data log analysis on 27-jun-2018, the gas system did not detect any problem with flow being different than the set point.

Manufacturer Narrative

The reported complaint was confirmed with information provided by the manufacturer's clinical specialist.The service repair technician (srt) was unable to duplicate the reported complaint.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: 7610752
• MDR Text Key: 111857363
• Report Number: 1828100-2018-00315
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)131220
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTERNAL BALL ANALOG FLOWMETER