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

Model Number 802018

Device Problem Output Problem (3005)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the flow module.Mechanical, electrical and visual testing was performed.The unit operated to the manufacturer's specifications.

Event Description

During field installation of the device, the field service representative (fsr) reported that the flow module failed testing.There was no patient involvement.

Manufacturer Narrative

During laboratory evaluation, the product surveillance technician (pst) connected the flow pod to lab use only (luo) testing equipment.There was no flow displayed on the screen when the pod was in use.The information on screen was as if there was no flow sensor attached.There were dashes displayed for the flow reading and a 'check sensor' message was displayed.With a luo generic printed circuit board (pcb) installed into the flow pod, the issue remained.With a luo application board installed into the flow pod, the flow displayed on the screen and the issue was corrected.The application pcb was the root cause of the reported complaint.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: 18142875
• MDR Text Key: 328983994
• Report Number: 1828100-2023-00348
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)230803
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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: Other
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1