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

Model Number 195240

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads would not adhere to the reservoir.As a result, level sensor pads from another box were used.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: d9 and h3 h3: 81 - evaluation is in progress, but not yet concluded.

Manufacturer Narrative

Per the perfusionist, the sensors were mounted on a flat surface on the bottom right of the reservoir and were connected within a minute of placement of the holder.During laboratory analysis, the product surveillance technician (pst) adhered 12 mounting pads to a lab use only (luo) cardiotomy / venous reservoir.The pads adhered very well and were removed with a flat head screwdriver and with significant effort.The pst did not observe any issues with the mounting pads.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.It was determined that the user was attaching the sensor to the mounting pad within a minute of applying the pad to the reservoir.The user was reeducated on the application of the mounting pads and advised to wait the full five minutes to allow full adhesion.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: 10950030
• MDR Text Key: 240813166
• Report Number: 1828100-2020-00471
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 10886799001704
• UDI-Public: (01)10886799001704(17)221031(10)938394
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• 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: 04/09/2021

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: Health Professional
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 01/22/2021; 02/24/2021; 03/23/2021
• Supplement Dates FDA Received: 02/13/2021; 03/17/2021; 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESERVOIR