MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 816300

Device Problem Inadequate User Interface (2958)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) touchscreen was not responding appropriately.It was noticed that there was fluid inside the screen.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was a 10 minute delay.There was no blood loss, nor adverse consequences to the patient.Per clinical review: during set up for a cpb procedure on (b)(6) 2020, the perfusionist was making adjustments on the ccm using the touchscreen with her finger when the cursor kept trying to go back to the bottom of the screen.After a closer inspection it appeared as if fluid had gotten into the screen through a small hole and settled at the bottom of the ccm.The biomedical engineer mentioned that the hospital cleaning staff uses a lot of cleaning fluid on the equipment and that could have caused the hole or the hole could have been there prior and the fluid got in due to excessive cleaning fluid.The team opted to exchange the ccm and the ccm and cable were removed from the heart lung machine (hlm) base and a back-up was placed onto the system to use for the case.There was about a ten minute delay in the start of the procedure.The procedure then proceeded with no blood loss or harm.

Manufacturer Narrative

The field service representative (fsr) verified the issue.The central control monitor (ccm) touchscreen was observed as not functional.The cursor did not work even with an external mouse connected.The end user reported to the fsr that there was liquid dropped on the screen and caused the damage.As a result, a loaner ccm was installed.The unit operated to manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the central control monitor (ccm) pointer gravitated towards the screen damage and was unable to be moved to select any applications.There was excessive scratching with one visible nick to the screen membrane.A lab use only (luo) touchscreen panel was installed in the ccm and it functioned as intended.It was determined that the touchscreen panel was defective, likely from the abrasive item used on the display.

Manufacturer Narrative

The reported complaint was confirmed.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: 10943105
• MDR Text Key: 219550439
• Report Number: 1828100-2020-00469
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001325
• UDI-Public: (01)00886799001325(11)171031
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1