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

Model Number 801763

Device Problem Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2018

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the batteries and the new batteries charged properly.He informed the user facility's biomedical engineer that the heart-lung machines (hlm) need to be periodically plugged into an alternating current (ac) outlet when not in use for a minimum of 24 hours to charge the batteries.The unit operated to the manufacturer's specifications.The suspect parts were sent back to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the battery level was extremely low.

Manufacturer Narrative

The reported complaint was confirmed.Per the field service representative (fsr), the heart lung machine (hlm) had been plugged in but not turned on, therefore, the batteries were not being charged.He turned the unit on and the batteries started charging as expected.The hlm was due for replacement batteries anyway so they were replace.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
• Type of Device: 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: 8178495
• MDR Text Key: 131793793
• Report Number: 1828100-2018-00652
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-04/08/2014-002-C
• Patient Sequence Number: 1