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 Problems Output Problem (3005); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) was not able to verify that the ccm was being/acting unresponsive.The fsr ran the system for a while using the ccm controls without having any issues.The ccm appeared normal, but a video from the perfusionist verified that the ccm was non-functioning.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) was not responsive.As a result, manual local controls were used.The surgical procedure was completed successfully.No other details regarding the nature of this event were provided.

Event Description

Per clinical review, on (b)(6) 2020 the clinical team had an incident with their central control monitor (ccm) on their heart lung machine during a cardiopulmonary bypass (cpb) procedure.During the procedure the ccm became non responsive to the touch of the user.They continued the procedure without issue using local controls.There was no delay in the continuation of the surgical procedure.There was no blood loss or harm related to the occurrence.

Manufacturer Narrative

The field service representative (fsr) replaced the central control monitor (ccm).The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.During laboratory analysis, the product surveillance technician could not verify the reported issue.The ccm was observed to function as it should for about 48 hours with quick clicking response of buttons.

Manufacturer Narrative

Updated block: h6 the reported complaint was confirmed.Per data log analysis, the log indicates that the hard drive was likely replaced so the system log does not cover the incident date of 03-nov-2020.The local area network / interface board (lan/if) log does cover the incident date and shows the central control monitor (ccm) likely froze as reported on 03-nov-2020 at 02:56:03.The lan i/f continued logging when the ccm froze causing input buffer overflows.The log does confirm the complaint.The service repair technician could not duplicate the reported issue.He observed the ccm to operate as intended throughout testing.The unit operated to the manufacturer's specifications.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: 10908675
• MDR Text Key: 221263649
• Report Number: 1828100-2020-00461
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001325
• UDI-Public: (01)00886799001325(11)150917
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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: 01/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1