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

Model Number 5773

Device Problem Device Alarm System (1012)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's field service representative (fsr), the non-clinical activity was the user facility using a trainer circuit to test a newly installed heart lung machine (hlm).The user facility noticed that the reservoir was draining, and that the abd alarm was not going off as large bubbles were passing through until there was a large amount of air.The abd and the abd module were swapped out one at a time with another and the issue was still present with the different combinations.During laboratory analysis, the product surveillance technician (pst) connected the abd sensor to lab use only (luo) testing equipment.Miscellaneous sized air bubbles were injected into the water loop.0.5 cubic centimeters (cc) of air was injected into the water loop, which should have caused the abd to alarm per specification, but the abd would not alarm.It was not until 0.7cc of air was injected that the abd alarmed.It was determined that the abd sensor did not operate to specification.

Event Description

It was reported that during use of the device for a non-clinical activity, the air bubble detector (abd) was letting large bubbles through without alarming.There was no patient involvement.

Manufacturer Narrative

Per the supplier evaluation, the sensor was installed into the test fixture and passed without adjustment.The sensor was tested by adjusting the bubble size to determine the detection threshold.The design specification is to be able to detect bubbles at a threshold of at least 500 microliters.The sensor showed some inconsistency while detecting around 300 microliters, but consistently detected at 310 microliters and above.The sensor performed as intended and met required design specification.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: 18135675
• MDR Text Key: 328089632
• Report Number: 1828100-2023-00345
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000038
• UDI-Public: (01)00886799000038(11)230821
• 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: 03/06/2024

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: 5773
• Device Catalogue Number: 5773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• 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