MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM

Model Number 164267

Device Problems Filling Problem (1233); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal drive motor stopped several times.The device was not changed out, as the perfusionist (ccp) hand cranked the drive motor.There was a delay of about three minutes as the troubleshooting and hand cranking was being performed.The surgical procedure was completed successfully, and there were no blood loss or no adverse consequences to the patient.Per the clinical review on (b)(6) 2013: set-up and priming was without issue.About ninety minutes into cpb, when the patient was at thirty degrees celsius, the ccp noticed the venous reservoir was filling with blood and then she heard a back flow alarm.The ccp observed the centrifugal control module was in the stop mode.She re-started the motor via the start / stop switch on the control module but was not able to increase the pump revolutions per minute (rpms).The ccp attempted to generate a pump speed and was not able to get the rpm above 300rpm and the motor would again stop.Hand cranking was started about thirty seconds later and continued about a minute.Again the motor was able to be started, but would keep going into the stop mode.Hand cranking again was performed to support the circulation of the patient.About three minutes after the motor initially stopped, the pump again was placed in the start mode and the perfusionist (ccp) was finally able to generate a pump speed of greater than 2000rpm and was able to adequately provide arterial flow for the patient.The remainder of cpb was without issue.The total time of loss of motor function was about three minutes.The ccp mentioned that she had heard after the case, that power surges were experienced in the operating room area during the procedure.She stated there were no alarms, alerts, or errors to indicate an issue with power within system-1.The ccp stated, the only alarms that occurred during this incident were back flow alarms.The procedure was completed successfully without associated blood loss.The patient was weaned from cpb after the procedure, without issue.There was no patient harm reported or observed.The ccp estimated the surgical procedure was delayed by about three minutes as the troubleshooting and hand cranking was being performed.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• 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: 3647642
• MDR Text Key: 4183065
• Report Number: 1828100-2013-01166
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• 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: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2010
• 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
• Patient Age: 81 YR