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 Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2018

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the electronic gas patient system (epgs) had a gas system failure.As a result, an alternate device was employed.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.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 the user facility's perfusionist, they attempted to calibrate the electronic patient gas system (epgs) as usual but was unable to after several attempts.The gas lines were checked for leaks, disconnected and reconnected but calibration still would not pass.The epgs was connected to gas lines in another operating room (or), calibration was initiated and passed.It was left running and after some time it was alarming and a red message appeared saying that the gas flow needed to be controlled by the manual controls.She tried to adjust the gas flow manually but no gas was coming from the epgs.Gas lines were checked for leaks, disconnected and reconnected but was unable to resolve the issue.Their circuits have oxygen (o2) and room air going directly from the or supply to the back of the pump.Tubing runs from the back of the pump to the vaporizer, then down to a dwyer air flow meter.From the flow meter the tubing connects to the oxygenator.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed that the gas system failure was a result of a defective internal flowmeter.He connected the electronic patient gas system (epgs) to a system 1 simulator and central control monitor (ccm) with zero air and oxygen pressure.The ccm displayed >10 even though there was no air flow.He replaced the internal flowmeter with a lab use flowmeter and the ccm, with no flow then showed 0 instead of >10.After the 15 minute warmup period, calibration of the epgs was initiated and passed.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

The field service representative (fsr) verified the reported complaint.He replaced the electronic patient gas system (epgs).The unit operated to the manufacturer's specifications.Per the suppliers evaluation, the unit was received reading 12.80 standards liters per minute (slpm) at zero flow.Analog outputs track correctly.Absolute pressure reading 17.95 at atmosphere (13.64 pounds per square inch (psia).Register inspection reveals differential output has shifted since time of production (sensor signal counts shifted from 9874 to 65362 and accounts for erroneous flow readings).Sensor bridge values have altered since production at factory (39100 to 32755) and accounts for erroneous pressure reading.These readings point to failure/detect in differential pressure sensor.Unfortunately, the sensor was damaged when the casing was removed so full analysis of the sensor cannot be conducted, nevertheless, a loose wire bond was identified by manual pull test.

• 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: 8078600
• MDR Text Key: 128052768
• Report Number: 1828100-2018-00594
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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

• 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: 12/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 12/04/2018; 12/14/2018; 01/11/2019; 04/17/2019
• Supplement Dates FDA Received: 12/12/2018; 01/08/2019; 02/05/2019; 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
• Treatment: DWYER AIR FLOW METER; OXYGENATOR; SECHRIST BLENDER; VAPORIZER