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 Out-Of-Box Failure (2311); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per the manufacturer's clinical specialist, the user facility had turned on the pump and initialized the perfusion screen.After the screen loaded an information window appeared that stated "knob control only for gas supply".The perfusionist dismissed that window and adjust the fraction of inspired oxygen (fio2) with the manual controls.The flow meter responded accordingly.When the perfusionist tried to use the slider control for the electronic patient gas system (epgs) there was no response.After the warm-up period, calibration was initiated and passed.All controls for the epgs were functional at this point.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, an information window appeared stating "knob control only for gas supply".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.As per the optical encoder resistor cross-section report, one failed part and one reference part were received.The resistor from the failed encoder has less silver epoxy under the end caps and smaller fillets than the reference.Some cracks or separations were observed in the joints of the resistor from the failed encoder between the resistor and the silver epoxy and the copper traces.The cracks observed in the joints of the resistor from the good encoder were likely induced during cross-sectioning indicating poor adhesion of the silver epoxy and encapsulation epoxy to the metal pad.The cracks in the silver epoxy could cause intermittent failures of this encoder.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

Based on the supplier's evaluation, the complaint unit's encoder with the unstable output channels were determined to have a disk gap of more than.012 inches which caused the failure.An optical encoder failure analysis report was also done with the failed part and a reference part, and it was found that the failed motor resulted in a non-uniform output signal of both channels.This is probably due to the motor skipping.The failed motor drew more current, and it was found that something in the failed motor prevents it from turning smoothly, causing the signal to lag.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 installed new electronic patient gas system (epgs).The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) connected the epgs to a heart lung machine (hlm) simulator and powered it on.He opened a perfusion screen and performed six consecutive power ups with no problem found.Powered off dut and placed into cold chamber at 10 degree celsius (c) for 75 minutes.Upon removal from cold soaking, the initial test failed and displayed the error message: ¿gas system: knob adjust only.The next three power up cycles passed.Power was then intentionally left off for one minute to allow cold to set back into the encoder (from the attached larger mass motor).Upon the next power up, the dut failed again, displaying the same message.The very next power up cycle passed.Left dut powered off again for another full minute.The dut then failed seven consecutive power on cycles.The dut then passed the next eight subsequent power on cycles with no error messages.The dut was then placed back into the cold chamber at 10° c for over 48 hours.Mode of failure was always the same.It has been determined that the cause is intermittent failure within the blender stepper motor with encoder assembly and intermittency may be aggravated by colder temperatures upon startup.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.

• 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: 7484396
• MDR Text Key: 107464355
• Report Number: 1828100-2018-00232
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

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
• Other Device ID Number: GTIN: (01)00886799000588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 05/08/2018; 08/15/2018; 10/05/2018
• Supplement Dates FDA Received: 06/01/2018; 08/28/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-10-05-18-006-C
• Patient Sequence Number: 1