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

Model Number 816571

Device Problems Communication or Transmission Problem (2896); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed per the data log analysis.The unit was not returned to the manufacturer therefore further evaluation could not be done.Per the manufacturer's subsidiary, the unit has been operating with no issues, and will return the unit should another issue arise.Per data log analysis, only the system log was provided.On (b)(6) 2020 a perfusion screen is opened at 08:24:29 am.At 08:25:46 am the arterial large roller pump reported an alarm.Most likely the pump had a low 5 volt (v) condition that caused the alarm.This would cause an alarm to sound and a red x on the pump icon as reported.At 08:33:31 am the art pump was reassigned to the vent position.Another alarm is reported on the pump and the perfusion screen is exited at 08:38:50 am.The log confirms the complaint.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

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed an 'x' over the pump icon.As a result, an alternative device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequence to the patient.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 10347224
• MDR Text Key: 201561714
• Report Number: 1828100-2020-00279
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 6885
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2012
• 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