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 Failure to Calibrate (2440)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the reported issue, the unit failed to calibrate due to high flow.He 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 set-up of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) would not calibrate.As a result, an alternative device was employed.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Per data log analysis, on (b)(6) 2019, each time gas system calibration was attempted it failed with "zero flow high before cal".Different flow values were recorded each time from 2.69 liters per minute (l/min) to 8.4 l/min.A power cycle did not correct the issue.The log confirmed the complaint.During laboratory analysis, the product surveillance technician (pst) observed the customer's electronic patient gas system (epgs) to fail calibration.Several components were replaced one at a time and calibration continued to fail.Once the flowmeter was replaced, calibration passed determining that the customer's flowmeter was defective.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.

Manufacturer Narrative

The reported complaint was confirmed.Per the supplier evaluation, there were no physical defects observed.Register values and adc sensor counts and all values were within normal and expected ranges when compared to the values at final quality inspection, with one exception, the unit returned with flow of +3.277 standard liters per minute (slpm) at zero flow condition.There was a very large and erroneous tare value though when returned to factory value, eliminated this behavior and returned flow reading to -0.001 at zero flow.While the device appeared normal, this erroneous value could have indicated that the device was tared in a failed condition or tared with a negative flow, so an intermittent failure is possible.Analog outputs were checked and all output readings corresponded correctly to digital flow readings.A cold chamber test was performed, and while higher flow was out of tolerance, this could easily be explained by the discrepancy between gas temperature and device temperature.As the temperature sensor inside the flow meter was allowed time to respond to the discrepancy, the flow data quickly returned to within normal bounds.As such, this temperature discrepancy did not appear to be the source of the failure.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

Additional information was received that the surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• 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: 9281426
• MDR Text Key: 196966096
• Report Number: 1828100-2019-00582
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)050106
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 02/13/2020
• Supplement Dates FDA Received: 01/23/2020; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1