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 Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr) the batteries were not fully charged as the unit had not been fully charged for a while.The fsr went over standard charging procedures with the perfusionist.As a precaution, and since the power plug on the original cord was replaced with a different one by the in-house biomedical technicians, the fsr replaced the power cord.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the battery light was red while the unit was plugged in.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed via data logs.The field service representative (fsr) returned to the user facility and replaced the batteries.The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) observed that upon receipt the batteries measured 12.9 volt direct current (vdc) for both batteries.Conductance measurements were 430 siemens (s) and 444s, both passing.Both batteries passed load testing with the batteries supporting the load for 66 minutes, 50 is the minimum requirement.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed nothing wrong with the power cord that would cause failure.He measured the continuity of the wires from one end of the power cord to the other.All continuity checks were good.The pst measured between the wires of the power cord for shorts, but no shorts were found.The cable was manipulated during testing which did not cause any failures.The power cord has been visually examined and found nothing that would cause the failure.Per data log analysis: 12:03:2018 7:55:22 pm low lmd: charging in float mode, this indicates that the battery cannot hold 18a/h 7:55:34pm system on battery backup 12/16 capacity 7:58:28pm system on battery backup 11/16 capacity 7:58:36 pm system shutdown ,still on battery backup.12/04/2018 11:54:31 am system power on, using battery backup 11/16 11:55:22 am start perfusion screen , using battery backup 10/16 11:57:16 am switch to ac charger is in bulk mode 12:00:55 pm switch to battery backup 12:05:52 pm end case 12:06:06 pm system shutdown, on battery backup 12:12:57 pm system power on, ac mode 12:13:41 pm start case on battery backup 12:15:11 pm on battery backup , ungraceful shutdown.The power manager reported low last measured discharge (lmd) at 12:13:2018 at 7:55:22 pm.This indicates that the battery cannot reach 18 amp hours (ah), and this will cause the power manager light emitting diode (led) to turn red when running on alternating current (ac).

• 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: 8178217
• MDR Text Key: 131006358
• Report Number: 1828100-2018-00649
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2019

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: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-03/13/2012-004-C
• Patient Sequence Number: 1