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

Model Number 893137

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) installed the flowmeter into lab use only (luo) testing equipment.The flowmeter passed all testing.The pst did not observe any anomalies.It was determined that the flowmeter met specification.

Event Description

Upon receipt of the device, the service repair technician (srt) reported when the flowmeter was set to 5.00 liters per minute (l/min) the flow output was 4.71 l/min which is outside the specification range of 4.80-5.20 l/min causing the test to fail.There was no patient involvement.

Manufacturer Narrative

Updated block: h6 the reported complaint was confirmed.Per supplier evaluation, as found, the calibration check was found to be out of tolerance as the flow reading was higher than the calibration reference, which would suggest that there was a leak during the calibration process.As a result of the leak during the initial calibration process, the device would register less flow than the calibration reference and apply higher than necessary system gain values in order to match the device to the reference.This would result in higher flow readings than actual.The direct material root cause of the leak during the calibration was determined to be a fitting used in the test stand between the reference and the device that was missing an o-ring.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 13695057
• MDR Text Key: 286865083
• Report Number: 1828100-2022-00099
• Device Sequence Number: 1
• Product Code: DTQ
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 893137
• Device Catalogue Number: 893137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1