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 Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, a 'battery cannot be charged: full battery backup may not be available' error message was displayed.No other details regarding the nature of this event were provided.

Event Description

Per clinical review: on december 10, 2019, the team powered on the heart lung machine (hlm) without issue.Set up, primed and commenced cardiopulmonary bypass (cpb) without concern or any error messages.A while into the procedure the team received a message stating - battery cannot be charged; full battery may not be available.The case continued without issue and without losing power.Of note, once the procedure was finished the team unplugged the hlm and the message disappeared, without reappearing.This incident did not delay the surgical procedure.There was no blood loss or harm associated with the event.

Manufacturer Narrative

The field service representative (fsr) could not duplicate the reported error message during multiple attempts to power on the unit.He checked the power supply wirings and battery performance.The unit operated to the manufacturer's specifications.Per data log analysis, on (b)(6)2019 when the system was powered up, a supply voltage failure for power supply 1 (ps1) was logged.The next few power ups no longer report ps1 as failed.On (b)(6) 2019 another supply voltage failure for ps1 is logged.This happened again on (b)(6) 2019 when the issue was reported to have occurred.This also caused the ps1 good signal to be bad which will cause the reported message "battery cannot be charged".The log indicates ps1 was intermittently failing at power up.

Manufacturer Narrative

The field service representative (fsr) returned to the user facility and replaced the power supply 1 (ps1) and the ps1 cable assembly given the information from the data logs of an intermittent power supply failure.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician observed the power supply to have a voltage reading of 0.1194 volts direct current (vdc) and specification for the voltage reading is 24.5 vdc +/- 5%.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: 9508718
• MDR Text Key: 199261717
• Report Number: 1828100-2019-00698
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)180516
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2020

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
• 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: 02/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/22/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 02/11/2020; 03/19/2020
• Supplement Dates FDA Received: 01/23/2020; 03/02/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1