MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)

Model Number 801046

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the display of the centrifugal control module blanked out.The device was not changed out as the customer rebooted and it worked fine to finish the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: the perfusionist (ccp) was using a sarns centrifugal pump (arterial) during this procedure and a level sensor was used in the alert only mode.An air bubble detector (abd) was configured, but was not enabled (used) for this procedure.In the conversation with the ccp, he mentioned that there were a couple of "low level" alert messages and the centrifugal motor went to coast (as configured).The ccp mentioned that shortly after the second "low level" alert message, the centrifugal control display blanked and arterial flow was lost.These incidents are posted in the data logs with "low level" alerts posted at 9:19:07 pm with coast speed response (1500 revolutions per minute [rpm]) and at 9:24:27 pm with coast response.The data logs also indicate a missing centrifugal module at 9:28:10 pm with a reboot (cp logical address) at 9:28:26 pm.These indicate a likely loss of power and communications (centrifugal control module) with a reboot 16 seconds later.A backflow alarm is also posted at 9:28:06 pm, which indicates the loss of forward flow.The logs indicate the motor was re-started at 9:28:32 pm with pump speeds of 1938 rpm at 9:28:43.This would indicate a loss of motor induced flow for about 40 seconds.The ccp indicated that he used the manual drive (hand crank) for a few seconds and when the control unit rebooted, he switched the pump head back to the motor.There is no other indication of loss of arterial flow during this procedure and the patient (according to the ccp) was weaned from cpb shortly after.According to the logs, the patient appears to have been weaned at 9:33:32 pm (about five minutes after blood flow was re-stored).According to the ccp, the procedure was completed successfully without delay and without associated blood loss.There was no harm observed during the procedure and/ or after the procedure in the intensive care unit (icu).

Manufacturer Narrative

This complaint is related to mdr #1828100-2014-01095.The field service representative (fsr) was unable to verify the reported complaint.The fsr operated the unit and checked the display.The display ribbon cable was reseated several times and operation checked.The perfusionist (ccp) mentioned that he would like the have just a "message only" response to an alert.The fsr reconfigured the ccp perfusion screen to meet this need.The fsr checked the operation of the centrifugal pump after reconfiguring and a "message only" appeared on the screen with audible and the centrifugal speed remained as set.The unit operated to manufacturer specifications and was returned to clinical use.The field service representative (fsr) did not replace any parts, therefore no parts will be returned to the manufacturer for evaluation.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: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4363788
• MDR Text Key: 5238229
• Report Number: 1828100-2014-01094
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801046
• Device Catalogue Number: 801046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2007
• 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
• Patient Outcome(s): Required Intervention