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 Problems Failure to Recalibrate (1517); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) downloaded data logs but was not able to record the existing oxygen (o2) sensor % hours.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 prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the flow knob on the electronic patient gas system (epgs) was spinning on its own and would not allow calibration.As a result, an alternate device was employed.Ther 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.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.Per supplier evaluation, upon receipt of the unit the flow reading was negative at zero flow.Sensor read counts had shifted from time of initial production from 10,170 to 1,148, which accounts for negative flow readings.Absolute pressure reading 19.09 pounds per square inch absolute (psia) at atmosphere (13.64 psia) due to sensor bridge count shift from 38,644 to 32,040.This failure is indicative of loose wire bonds and accounts for failure to integrate flow meter into gas system.The flow meter was opened and connections tested with no defective solder joints discovered.Two loose wire bonds just resting on their respective pads identified.These loose wire bonds determined to be the source of the erroneous sensor readings.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed that the flow knob was spinning and clicking on its own and the gas system would not allow calibration.During calibration, the actual air flow out of the electronic patient gas system (epgs) did not stop at the usual calibration rate of five liters per minute (l/min) but instead, kept increasing to maximum flow.The voltage output of the internal flowmeter was five volts (v) no matter what the flow rate was.It was determined that the internal flowmeter was the cause of the problem.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Per data log analysis, on (b)(6) 2018 (based on the date/time set on the central control monitor [ccm]) at 6:22:33 am the gas system was successfully calibrated.At 6:46:13 am flow was set to 3.01 l/min using the ccm slider.At 6:46:44 am the gas system reported "flow motor/mechanical fault".This indicates the gas system was not able to achieve 3.01 l/min of flow because of a hardware issue with the gas system.This could also result in the flow knob clicking and spinning as reported.Since the issue was reported to have happened on (b)(6) 2018, it's likely the date/time is not set correctly on the ccm.

• 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: 8021318
• MDR Text Key: 125780632
• Report Number: 1828100-2018-00564
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)080707
• 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,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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: 10/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-04/08/19-002-C
• Patient Sequence Number: 1