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

Model Number	806455
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During testing the fsr found that the occluder head was causing the occluder module to reset, and lose calibration.He replaced the occluder head.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.
Event or Problem Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the occluder head was losing calibration.There was no patient involvement.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed the occlude to successfully pass calibration.The occluder was opened and closed 10 times and there was no occasions of it losing calibration.When fully occluded no water passed through the tubing.
Additional Manufacturer Narrative
The reported complaint was confirmed.The service repair technician (srt) was unable to duplicate the reported issue.The occluder head was observed to function properly throughout the evaluation.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: 10726710
• Report Number: 1828100-2020-00405
• Device Sequence Number: 4087018
• Product Code: DTQ
• UDI-Device Identifier: 00886799000878
• UDI-Public: (01)00886799000878(11)180412
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/28/2021

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: Other
• Device Model Number: 806455
• Device Catalogue Number: 806455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 03/02/2021; 04/15/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/08/2021; 03/24/2021; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1