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

Model Number 816300

Device Problems Device Operates Differently Than Expected (2913); Inappropriate or Unexpected Reset (2959)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per log analysis, this occurred multiple times but never when a perfusion screen was opened.The other non-target errors that occurred in the log were "pcmcia supply error" where the 12 volt (v) was reporting high.The field service representative (fsr) was unable to duplicate the complaint.He replaced the ccm with a loaner.The unit operated to the manufacturer's specifications.The suspect unit was returned to the manufacturer for further evaluation.

Event Description

It was reported that during log analysis of the device, there was a "5v supply voltage" test failure causing the central control monitor (ccm) to reboot.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the central control monitor (ccm) to reboot when operated at reduced temperatures.The output voltage of the direct current (dc) power supply was measured and resulted in abnormally high voltage.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: 7407976
• MDR Text Key: 105278577
• Report Number: 1828100-2018-00179
• 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: 05/25/2018

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: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1