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

Model Number	802114
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, one channel of the temperature module was not working.As a mitigation, only one channel was used.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2020, the clinical team noticed that one of the temperature channels on the temperature module was not working.They decided to place the temperature cord/thermistor in the other channel and the temperature was able to be displayed on the central control monitor (ccm) the remainder of the procedure.This temperature issue did not delay the continuation of the surgical procedure.There was no harm or blood loss due to this concern.
Additional Manufacturer Narrative
H3, 81: evaluation is in progress, but not yet concluded.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician observed the temperature module to work as intended on both channels.Two temperature probes, one set for 4.9 degrees celsius (c) and the other 18.0 c, were used and the values on the central control monitor matched the probe values.The red and blue channel were tested separately and then again simultaneously and all reporting values were accurate.
Additional Manufacturer Narrative
The reported complaint was not confirmed.Per data log analysis, on (b)(6) 2020 the log shows channel 1 of the temperature module changing status between in range, to under range, to disconnected but winds up in range.Channel 2 of the temperature module was changing status between in range, to under range but winds up in range.Both channels continued this behavior with no clear indication that one channel had an issue.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
• MDR Report Key: 10673056
• Report Number: 1828100-2020-00387
• Device Sequence Number: 2670921
• Product Code: DTQ
• UDI-Device Identifier: 00886799000748
• UDI-Public: (01)00886799000748(11)200804
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/28/2021

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: 802114
• Device Catalogue Number: 802114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 11/24/2020; 01/26/2021; 03/11/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/18/2020; 12/16/2020; 02/18/2021; 03/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1