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

Model Number 5773

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

As per the perfusionist, multiple different placements and resets were attempted, but the sensor would only alarm when engaged.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the ultrasonic air sensor (uas) would only alarm when engaged.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint could not be confirmed.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 indicated that the air bubble detector (abd) would alarm when there was no bubble present.They tried different areas on the circuit and it still alarmed.

Manufacturer Narrative

Per the user facility, the air bubble detector (abd) was connected to the arterial pump below the reservoir at the time of the reported complaint.The latch was secure and the sensor cables were checked with no issues found.

Manufacturer Narrative

During laboratory evaluation, the product surveillance technician (pst) observed no failure of the air bubble detector (abd) to alarm in the presence of air.

• 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: 8176447
• MDR Text Key: 131478108
• Report Number: 1828100-2018-00648
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• 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,Followup
• Report Date: 05/20/2019

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: 5773
• Device Catalogue Number: 5773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/01/2019; 03/15/2019; 04/26/2019
• Supplement Dates FDA Received: 01/26/2019; 04/08/2019; 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESERVOIR