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

Model Number 195274

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The srt tested the level sensor on three different level pods getting the same result.The level sensor was replaced.The unit operated to the manufacturer's specifications.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

The service repair technician (srt) reported that during routine testing of the device at the service center, the level sensor was not recognized by the level pod.There was no patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the level sensor to fail due to an intermittent open connection within the cable, near the module connector end.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
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7280603
• MDR Text Key: 100547727
• Report Number: 1828100-2018-00083
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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: 195274
• Device Catalogue Number: 195274
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1