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 Fluid/Blood Leak (1250)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

Upon receipt of the device, the service repair technician (srt) reported that the flowmeter had an internal leak.There was no patient involvement.

Manufacturer Narrative

Per the srt, the electronic patient gas system (epgs) failed leak testing with no visual leak detected, indicating an internal leak.The srt replaced the flowmeter and the epgs passed leak testing.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.Per supplier evaluation, the device was received and inspected and all readings and registers were within tolerance.The device was leak checked with 100 pounds per square inch (psi) of air and failed with a leak rate of 1.8 cubic centimeters per minute (ccm).Further testing was done with 30psi of helium to determine the leak location.The failure point was found to be at the base of the differential pressure sensor.The leak was not significant enough to affect device flow readings during standard usage.It appeared to be a failure of the epoxy on the sensor and units from the same batch have had no failures reported.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: 14550104
• MDR Text Key: 294141135
• Report Number: 1828100-2022-00213
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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: 07/12/2022
• 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