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

Model Number 816570

Device Problems Out-Of-Box Failure (2311); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per fsr, the roller pump continued to display the error message after rebooting and trying a new power cable.He installed a new roller pump.The unit operated to the manufacturer's specifications.The suspect unit was returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during the first power up of the unit after installation, the pump displayed a "service pump" error message.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2018 the pump logged many "display supply error - under range (7.27 to 8.06 v)".This will cause the pump to display "service pump" as reported, as long as the display still functions.During laboratory analysis, the product surveillance technician (pst) verified the reported complaint.He observed the pump to power on with no display due to a disconnected display to pump pod ribbon cable.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: 7458328
• MDR Text Key: 107080492
• Report Number: 1828100-2018-00207
• 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
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

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: 816570
• Device Catalogue Number: 816570
• Other Device ID Number: GTIN: (01)00886799001363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1