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 Mechanical Jam (2983); Output Problem (3005)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump displayed a 'pump jam' message and would not turn.As mitigation, the perfusionist tried tightening and loosening the occlusion, and the pump would spin freely when there was no resistance.However, when the occlusion got tight it would read '.001 pump jam', stop and was unable to create flow.As a result, an alternate device was employed.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

H3: 81 - evaluation is in progress, but not yet concluded.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Updated blocks: h3 and h6 during laboratory analysis, the product surveillance technician (pst) connected the roller pump to lab use only (luo) testing equipment.It was found that there were several instances of a 'belt slip jam status' in the event logs.With 1/4 inch tubing loaded, the occlusion knob increased to maximum occlusion with no pump jam.With 3/8 inch tubing loaded, a pump jam did occur and then occlusion could be backed off while maintaining flow without jamming.When a pump jam was induced, there was no belt slip message before the jam message.Pump jams did not occur unless the pump was over-occluded.The service repair technician was not able to duplicate the reported issue.The pump functioned as intended, without jams, unless induced.The pump was disassembled and no anomalies were found.Preventative maintenance and release testing was performed.The unit operated to the manufacturer's specifications.

• 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: 18312374
• MDR Text Key: 330465799
• Report Number: 1828100-2023-00368
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001363
• UDI-Public: (01)00886799001363(11)180716
• 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
• Report Date: 02/21/2024

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: 816570
• Device Catalogue Number: 816570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 01/31/2024
• Supplement Dates FDA Received: 01/24/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2018
• 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