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

Model Number	889773
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Upon receipt of the device, the user reported that the electronic patient gas system (epgs) oxygen (o2) sensor failed calibration.There was no patient involvement.
Additional Manufacturer Narrative
Per the manufacturer's subsidiary's service technician, the reported issue occurred during testing of the sensor on the equipment.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed the output of the oxygen (o2) sensor to be 9.2 millivolts (mv) which was within the expected range of 9 - 13 mv.He installed the o2 sensor into a lab use only (luo) electronic patient gas system (epgs).Calibration was successful and the output of the epgs was found to be steady and accurate.A second calibration was also successful.The sensor operated as expected.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
• Common Device Name: 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: 18544019
• Report Number: 1828100-2024-00024
• Device Sequence Number: 7945860
• Product Code: DTQ
• UDI-Device Identifier: 04250320600725
• UDI-Public: (01)04250320600725(11)231017(17)250417
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Other
• Device Expiration Date: 04/17/2025
• Device Model Number: 889773
• Device Catalogue Number: 889773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown