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

Model Number 801763

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed a red x on the flow icon.The flow sensor was wiped and reapplied and the flow reading returned.Shortly after, the red x appeared again.The system was rebooted and the flow reading returned and worked without issue for the remainder of the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The fsr confirmed the reported complaint through the logs.It was determined that the left network interface card (nic) board was the cause of the issue.The fsr replaced the left nic board.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) installed the left side network interface card (nic) into lab use only (luo) testing equipment.It was monitored for 24.75 hours and was unable to duplicate the reported complaint.Upon microscopic examination, the pst observed an anomaly with the resistor at the r1225 position on channel 12 of the nic which was damaged.This was the location the end user had their flow module plugged into when the 'red x' displayed on the ccm.It was determined that the nic did not meet specification.Per data log review: on (b)(6) 2022, the system log showed a perfusion screen was opened at 06:40:25 am.At 08:06:56 am the flow meter reported '7.5 volts (v) supply out of range alert; 5v supply out of range alert'.This occurred three times by 08:26:52 am.The flow meter log showed many 5v and 7.5v failures as well.This is likely the cause of the 'red x' on the flow meter icon.The log confirms the 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: 13359752
• MDR Text Key: 285649401
• Report Number: 1828100-2022-00030
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)171017
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

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: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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