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 Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the heart lung machine (hlm) had issues with network interface controller (nic) board causing a red 'x' on the level sensor icon.There was no patient involvement.

Manufacturer Narrative

The field service representative replaced the network interface card.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician observed port three on the network interface card (nic) panel to be unreliable.A module connected to that port showed an unstable connection until a red 'x' appeared on the central control monitor (ccm).The issue was not observed on any of the other ports.He observed no electrical output on one of the pins related to the port three connection.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: 10931574
• MDR Text Key: 219369509
• Report Number: 1828100-2020-00466
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)200103
• 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,Followup
• Report Date: 04/01/2021

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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 01/26/2021; 03/25/2021
• Supplement Dates FDA Received: 02/18/2021; 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1