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

Model Number 801188

Device Problem Output Problem (3005)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified that the oxygen (o2) sensor hours were exceeded per the electronic patient gas system (epgs) log.The epgs was replaced.The unit operated to the manufacturer's specifications.Per data log analysis, it was found that the date changed on the ccm, causing the year to appear to be much later than actual which caused the 'service gas system' message to appear.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed a 'service gas system' message.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The service repair technician (srt) could not duplicate the reported complaint.The electronic patient gas system (epgs) was powered on and air and oxygen (o2) were introduced.The o2 analyzer calibrated successfully and all testing passed.The unit operated to the manufacturer's specifications.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: 18830875
• MDR Text Key: 336875963
• Report Number: 1828100-2024-00073
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)201009
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2020
• 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