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

Model Number	801764
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was discovered during installation and commissioning.Per the manufacturer's subsidiary, the batteries were charged for 24 hours but were not storing any charge when alternating current (ac) power was disconnected.
Event or Problem Description
It was reported that during the use of the device for a non-clinical activity, the batteries were charging fully but not capable to store the charge.There was no patient involvement.
Additional Manufacturer Narrative
The reported complaint could not be verified.Per the manufacturer's subsidiary, the end-user charged the heart lung machine (hlm) for 24 hours, but it did not store any charge in the batteries when the alternating current (ac) power was disconnected.No part will be returned for evaluation at this time, the distributor may be disposing the batteries locally.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: 8615108
• Report Number: 1828100-2019-00250
• Device Sequence Number: 2294657
• Product Code: DTQ
• UDI-Device Identifier: 00886799000663
• UDI-Public: (01)00886799000663(11)180607
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 801764
• Device Catalogue Number: 801764
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1