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 Leak/Splash (1354)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the end-user continued to use the hose by sealing it with plastic tape.Damage was found to the tubing around the hole.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, there was air leaking from the yellow compression gas hose.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per terumo subsidiary, the hose was replaced at the customer site.Therefore no hose replacement is required.

Event Description

Per clinical review: during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2020.It was noticed that there was a tiny leak on the yellow (medical grade gas) line during the procedure.The team used heavy tape and taped up the little crack in the line.The team was able to continue the procedure without issue, without a loss in the fraction of inspired oxygen (fio2) level.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss due to the incident.

Manufacturer Narrative

The reported complaint was confirmed via information obtained from the manufacturer's subsidiary.No parts were returned so an evaluation could not be completed.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: 11059686
• MDR Text Key: 223778335
• Report Number: 1828100-2020-00499
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1