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 Problems Battery Problem (2885); Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2020

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr) the user facility's biomedical engineer stated that there were power issues in the operating room.

Event Description

It was reported that the heart lung machine (hlm) had a battery error issue.No other details regarding the nature of the event were provided.

Manufacturer Narrative

The reported complaint was confirmed.The product surveillance technician duplicated the reported complaint.He observed the voltage to be too low that it was unable to power on the fans of the power supply's.The voltage was reading 0.112 volts direct current (vdc), specification 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.

Event Description

Additional information received that the surgical procedure was completed successfully.No adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate any issues.After consulting further with the user facility's biomedical technician it was determined that a bad power outlet caused the heart lung machine (hlm) to go onto battery power without the user knowing.There are no issues with the battery or the hlm.

• 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: 11023400
• MDR Text Key: 224410994
• Report Number: 1828100-2020-00480
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)190731
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• 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
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1