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 Problem Mechanical Problem (1384)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb) the roller pump occlusion was uneven.When the roller was at one point in the raceway, the tubing was fully occluded, but at another point, the pump was allowing fluid through.The surgical procedure was completed successfully.There was a reported delay of one hour.There were no reported adverse consequences to the patient.No other details regarding the nature of this event were provided.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) connected the roller pump to a tubing test loop with water.The pump did not show any inconsistency with occlusion from roller to roller, and the fluid was advanced forward as the rollers advanced with no back flow.Only a brief pause was observed as one roller engaged with the race and the other disengaged which was typical behavior of the roller pump.The pump operated as intended.The pst noted that in the video sent with the complaint record, the tubing was seen to be taut rather than follow the contour of the raceway around, which could have an affect on the occlusion.

Event Description

Per clinical review: on (b)(6) 2023, the team at the user facility experienced a problem with the heart lung machine large six inch roller pump occlusion.The complaint document indicated that the issue occurred during cardiopulmonary bypass, with a 1-hour delay, and successful completion of the procedure, but does not indicate if the product was changed out or if there was any blood loss.However, review of the video sent by the user indicated that the issue was discovered after the surgery had started, but most likely before cardiopulmonary bypass (during prime), as the roller pump in question had dual tubing in it, of different sizes, indicating it may be a cardioplegia pump, and there is no blood in either tubing, which would indicate that the patient was not on cardiopulmonary bypass yet.Also, although it is very difficult to see the entire pump circuit, there is no visible blood in any other tubing on the hlm, which would also be consistent with the issue being discovered during prime, after the beginning of the surgery, but before cardiopulmonary bypass.Attempts at gathering more information and clarification of details was made but no response was given.Also, while the condition of uneven occlusion that was illustrated in the video may be due to a problem with the roller head or the occlusion mechanism, it could also be due to inconsistency in the tubing itself.Because the video illustrated that the unevenness occurred in the 8 o'clock vs the 4 o'clock position of both rollers, that would eliminate the possibility of the rollers themselves being improperly set and would either suggest an unevenness in the raceway, or an unevenness in the disposable tubing.Since proper occlusion setting is already a challenge with different sized tubing in the same raceway, it would consider a possibility that the problem that was illustrated in the video could have been due to tubing variance as opposed to a problem with the roller pump itself.

Manufacturer Narrative

81 - evaluation is in progress, but not yet concluded.

• 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: 18314425
• MDR Text Key: 330937204
• Report Number: 1828100-2023-00370
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)220523
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 02/14/2024; 03/11/2024
• Supplement Dates FDA Received: 03/07/2024; 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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