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

Model Number 816570

Device Problems Pumping Stopped (1503); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the roller pump.Release testing was performed and passed.The unit operated to the manufacturer's specifications.

Event Description

During field installation of the device, the field service representative (fsr) reported that the roller pump displayed an 'overspeed' message and turned off as soon as the pump started turning.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) connected the roller pump to lab use only (luo) testing equipment.No failures could be reproduced during the evaluation, but the event log did indicate instances of 'opto sensor disconnected/broke err' which is related to overspeed messages.The pump was left operating at maximum rotation rate for two hours with no disruptions observed.The opto sensor appeared to be properly mounted, internal cabling appeared to be intact, and no overspeed events could be reproduced without intentionally causing them.The pump operated as intended.

Manufacturer Narrative

The service repair technician (srt) performed external and internal physical inspection and discovered the drive belt had damage present that could potentially cause the reported issue.He replaced the drive belt and associated parts.The unit operated to the manufacturer's specification.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18687083
• MDR Text Key: 336208986
• Report Number: 1828100-2024-00048
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 816570
• Device Catalogue Number: 816570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1