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

Model Number 816571

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump was very hard to occlude and made a grinding sound.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) verified that the pump was making a rough grinding noise.He replaced the pump.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

Updated block: d9.During laboratory analysis, the product surveillance technician (pst) connected the roller pump to lab use only (luo) testing equipment and powered it on.The pst occluded and unoccluded the roller pump and compared the resistance to luo roller pumps.The resistance was observed to be comparable.The pst monitored the roller pump for grinding noise, which was not heard.The roller pump was inspected and found to be clean and free of grease.It was determined that the roller pump met specification.

Manufacturer Narrative

Updated block: b5.

Event Description

Per clinical review: on (b)(6) 2021, the team experienced an issue with the heart lung machine (hlm) whereby a six inch roller pump was noted to be very hard to occlude.This occurred during cardiopulmonary bypass (cpb).There was no delay, no blood loss, no change out, and the procedure was completed successfully.

Manufacturer Narrative

The reported complaint was not confirmed.The service repair technician (srt) did not duplicate the reported complaint.The roller pump was release tested.The unit operated to the manufacturer's specifications.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: 13061510
• MDR Text Key: 285574072
• Report Number: 1828100-2021-00488
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)210320
• 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,Followup,Followup
• Report Date: 04/07/2022

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/12/2022; 02/04/2022; 03/24/2022
• Supplement Dates FDA Received: 02/03/2022; 02/28/2022; 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2021
• 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