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

Model Number 806455

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

The reported issue was found during routine testing at the hospital.As per the manufacturer's subsidiary, there was no fire, no smoke, no sparking, and no electrical fault during the process.

Event Description

It was reported that during use of the device for a non-clinical activity, the occluder head became hot.There was no patient involvement.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) observed the occluder to operate as intended with no heat coming from the occluder.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

H3: 81 evaluation is in progress, but not yet concluded.

Manufacturer Narrative

Updated blocks: h3 and h6.During laboratory analysis, the product surveillance technician (pst) observed that the occluder head functioned as intended and remained cold to the touch.Inspection revealed no signs of damage or overheating.

• 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: 8524514
• MDR Text Key: 142408124
• Report Number: 1828100-2019-00193
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 806455
• Device Catalogue Number: 806455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1