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

Model Number 801040

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the manufacturer's subsidiary, the issue was discovered during routine maintenance of the pump.The pump was working roughly and moved with difficulty.

Event Description

It was reported that during the use of the device for a non-clinical activity, the pump was not functioning correctly.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the pump to be improperly reassembled with three functional issues.He noted a disconnected lid switch causing a 'cover open' error message, a disconnected encoder pin #2 causing an 'over-speed' error message and a loose tension nut causing an 'under-speed' error message.The reconnection of connectors and proper tension nut adjustment corrected all three issues and restored pump functionality.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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: 7479775
• MDR Text Key: 107745497
• Report Number: 1828100-2018-00222
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2018

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: Health Professional
• Device Model Number: 801040
• Device Catalogue Number: 801040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/10/2018; 06/26/2018
• Supplement Dates FDA Received: 06/04/2018; 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1