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

Model Number 802111

Device Problem False Alarm (1013)

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

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) checked the alert and alarm settings and he could not duplicate the error.The unit operated to the manufacturer's specifications.

Event Description

It was reported that the level sensor was constantly alarming.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, the complaint indicates the issue occurred on 29-jan-2020, but there are no events from that date.On (b)(6) 2020 the level sensor was reporting coupled, uncoupled, and disconnected events on the alert probe.On (b)(6) 2020 the level was reporting coupled, disconnected events on the alert probe again.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: 9735448
• MDR Text Key: 198540108
• Report Number: 1828100-2020-00077
• Device Sequence Number: 1
• Product Code: DTQ
• 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: 04/02/2020

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: 802111
• Device Catalogue Number: 802111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1