MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (CCM)

Model Number 816300

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) seemed to have froze.Error message "no system computer" was displayed on all the roller pumps.The ccm could not be used by touch panel.The device was not changed out, as the clinical engineer used the manometer and analog flowmeter for this case.The surgical procedure was completed successfully.There were no delays, no blood loss, nor adverse consequences to the pt.The clinical engineer rebooted the system after the case.After the system was rebooted, the reported issue was canceled.Per clinical review on 12/03/2014: since this occurred during cpb, a perfusion screen would have been selected and active and safety sensors (air bubble detector, level, and pressure) would have been enabled.The subsidiary report states that all pumps continued to function and would have been able to be controlled and monitored with the local displays.As reported, the clinician used pressure manometers and analog gas flow meters to monitor real time gas flows and cpb circuit pressures.In spite of ccm issue, safety systems would continue to function and alert the user of clinical issues.Nothing was changed out or re-booted during cpb.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

Eval is in progress, but not yet concluded.The subsidiary's mfg engineering center (mec) could not duplicate the reported issue.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (CCM)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4355879
• MDR Text Key: 20979153
• Report Number: 1828100-2014-01083
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2014

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: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ANALOG FLOWMETER; MANOMETER