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	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the user facility was advised to fully charge the battery overnight prior to the first clinical use, resolving the issue.This complaint is related to (b)(4) / medwatch #1828100-2019-00032.
Event or Problem Description
It was reported that during installation of the heart lung machine (hlm), the batteries were depleted.There was no patient involvement.
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the unit was installed in the user facility in december 2018 and the batteries had not been charged while the unit was in the distributor's warehouse.After charging the batteries the unit was operating as intended.
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: 8293607
• Report Number: 1828100-2019-00052
• Device Sequence Number: 1734628
• Product Code: DTQ
• UDI-Device Identifier: 00886799000663
• UDI-Public: (01)00886799000663(11)180614
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Report Date (Section B): 06/10/2019

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: 01/21/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 06/07/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/07/2019; 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1