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 Code	No Patient Involvement (2645)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) verified that the temperature module would not connect to the system.The temperature module light emitting diode (led) would not light up and was not recognized by the system.The temperature module was replaced.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.
Event or Problem Description
Upon receipt of the device, the user reported that the temperature module did not work and would not connect to the heart lung machine (hlm).There was no patient involvement.
Additional Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the temperature pod assembly to function normally during both ambient temperature and cold chamber testing.Per data log analysis, on (b)(6) 2019, the temperature module was used.Next entry was on (b)(6) 2020, most likely from the laboratory evaluation.Since the issue was the module not connecting to the heart lung machine (hlm) on (b)(6) 2019 it was likely nothing would be logged.The only indication of a problem in the log is the lack of log entries.There was no way to tell if the module was actually plugged into the hlm.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: 9343808
• Report Number: 1828100-2019-00606
• Device Sequence Number: 2208315
• Product Code: DTQ
• UDI-Device Identifier: 00886799000748
• UDI-Public: (01)00886799000748(11)190425
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K022947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2020

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: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 01/20/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/06/2019; 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1