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

Model Number 802114

Device Problem Output Problem (3005)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's technical support specialist, the end user reported that the module light emitting diode (led) was green, meaning it was operational.The field service representative (fsr) could not verify the reported complaint.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial and venous temperatures did not display on the central control monitor (ccm).No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, there is no indication of a problem in the log until about three minutes before the perfusion screen is exited.Both art temp and ven temp probes report being disconnected which will cause the temperature to not be displayed on the ccm as reported.Per the field service representative, the user had two perfusion screens set up and were possibly looking at the incorrect perfusion screen.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

Per clinical review: on (b)(6) 2020 during a cardiopulmonary bypass (cpb) procedure at the clinical team had issues with temperature sensing system.No other information was given at this point.Per information available, the user stated that temperature sensing system during a procedure was not displaying the arterial and venous temperature on the central control monitor (ccm).Per the log data, the arterial and venous temperatures were reading from 6:02am to 13:06, and the sensors were disconnected at 14:16 and 14:17.The team had changed the temperature alarm ranges during the procedure.It is unknown what the concern or issue was, and how it was mitigated.It is unknown about a delay or harm.There is routinely no blood loss related to this issue.There is typically no delay or harm due to this issue.

• 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: 10924848
• MDR Text Key: 221284701
• Report Number: 1828100-2020-00465
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000748
• UDI-Public: (01)00886799000748(11)180202
• 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
• Report Date: 01/27/2021

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: 802114
• Device Catalogue Number: 802114
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1