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

Model Number 816571

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr), could not verify the reported complaint.The perfusionist stated the system had gotten wet, per the fsr, the heart lung machine (hlm) was dry during testing.All system calibrations and operations were checked.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump was not turning on.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 could not be 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.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

Additional information was received from the perfusionist that when the base was powered on, the central display screen and the other roller pumps powered up except the one in question.They changed out the roller pump with another one to resolve the issue.Per data log analysis, the log shows the issue likely occurred on (b)(6) 2020.At power up on (b)(6) 2020 there were two large roller pumps, module id 04893 and 03904.At 09:16:32 am, the central control monitor (ccm) reported 'error pod operational status timeout' and based on the data it was a large roller pump module id 04893 (arterial).The log for the arterial pump showed many 'ewrn can' errors on (b)(6) 2020 indicating issues sending data.The ccm stopped logging 09:17:25 am and then powered up at 09:18:50, almost like it rebooted or was power cycled.Indications on the other pumps is that the system was power cycled.When the system powered up, large roller pump module id 04893 was missing.At 09:18:55 am the ccm stops logging again and is powered up at 09:32:26 am, large roller pump 04893 is still missing.At 09:47:31 am the ccm stops logging again.Large roller pump 04893 is still missing.A perfusion screen is opened at 11:30:39 am.The perfusion screen is exited and the ccm is shutdown.The next power up is on (b)(6) 2020 and now there are two large roller pumps, module id 04893 and 06982.When the logs were exported a log for large roller 03904 was provided.It is possible large roller 03904 was causing issues and was replaced.

• 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: 10874862
• MDR Text Key: 224410104
• Report Number: 1828100-2020-00447
• 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
• Report Date: 03/15/2021

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/24/2020; 02/16/2021; 03/12/2021
• Supplement Dates FDA Received: 12/03/2020; 03/12/2021; 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1