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

Model Number	802111
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the level sensor detector malfunctioned.The surgical procedure was completed successfully.There was no delay, no blood loss, no adverse consequences to the patient.
Additional Manufacturer Narrative
This complaint is related to (b)(4) / mfr# (b)(4).
Event or Problem Description
Per clinical review: on (b)(6) 2021, the team experienced a problem with a level detector malfunction on their heart lung machine (hlm), while on cardiopulmonary bypass (cpb).This was the second occasion of a similar malfunction.The manufacturer's clinical specialist spoke with the perfusionist and he stated that the level was giving a false notification, as the actual level in the venous reservoir was well above the sensor level.He eventually turned off the level detection system and completed the case successfully, with no delay, blood loss and no adverse event.
Additional Manufacturer Narrative
The field service representative (fsr) did not find any issues with the red level sensor.He did replace the level sensor module and the yellow level sensor.The level sensor module was part number: 802111, serial number: (b)(6) , udi: (b)(4).The yellow level sensor was part number: 195215, serial number: (b)(6) , udi: (b)(4).The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
The reported complaint was confirmed.It was determined to update this complaint to be written on the level module since that unit was returned for evaluation rather than the level sensor which was determined by the field service representative (fsr) to operate to the manufacturer's specification.During laboratory analysis, the product surveillance technician (pst) connected the level detector module to lab use only (luo) testing equipment.The unit ran for 3.68 hours testing the alert/alarm system with no observation of any level detector malfunction.It was determined that the level detector module met specification.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: 13546140
• Report Number: 1828100-2022-00061
• Device Sequence Number: 5201476
• Product Code: DTQ
• UDI-Device Identifier: 00886799000717
• UDI-Public: (01)00886799000717(11)210311
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2022

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: Health Professional
• Device Model Number: 802111
• Device Catalogue Number: 802111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 03/28/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/21/2022; 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown