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

Model Number	802110
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fsr replaced the abd module.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.
Event or Problem Description
The field service representative (fsr) reported that during field service installation of the heart lung machine, the air bubble detector (abd) failed.There was no patient involvement.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician observed that when the customer air bubble detector (abd) module was used with the lab-use only abd sensor and a water loop, as soon as the module was configured and armed, the abd began alarming without the air bubble being present.The green light on the module was red signifying a problem with the module.
Additional Manufacturer Narrative
Additional testing done by the product surveillance technician determined that the c3 tantalum capacitor on the application board had overheated and burned causing the air bubble detector (abd) to fail.Per data log analysis, the abd log only shows many 'starting application' events at the start of the log.Most likely when the issue occurred the abd was rebooting so many times that the event preceding the issue was purged.There are no five volt spikes in the system log for the power manager.There is no way to tell for sure if there was a voltage spike or not from the log but there is no indication of one.
Additional Manufacturer Narrative
The reported complaint was confirmed.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: 10836267
• Report Number: 1828100-2020-00440
• Device Sequence Number: 16900223
• Product Code: DTQ
• UDI-Device Identifier: 00886799000700
• UDI-Public: (01)00886799000700(11)200803
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2021

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: Other
• Device Model Number: 802110
• Device Catalogue Number: 802110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 01/25/2021; 03/23/2021; 04/16/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/15/2021; 04/15/2021; 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1