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 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) installed the flowmeter into a lab use only (luo) electronic patient gas system (epgs).Verification/release testing was conducted and the pst observed the flowmeter to function as intended and pass all testing.

Event Description

The service repair technician (srt) reported that during testing of the device at the service center, the flowmeter failed accuracy testing.There was no patient involvement.

Manufacturer Narrative

Updated block: h6 the reported complaint was confirmed.Per supplier evaluation, the device was out of tolerance and found to have values 6% high.The device was shipped with system gain of 42.88 and recalibrated to 40.21.The higher system gain was evidence there was a leak during calibration and 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.The higher system gain was evidence that the calibration process compensated for the leak present during the device's original calibration.The recalibration with lower system gain with no leak present further verified this.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: 13760033
• MDR Text Key: 287284243
• Report Number: 1828100-2022-00107
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• 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: 03/14/2022
• 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