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

Model Number 6379

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor on centrifugal pump was not reading values.The device was not changed out.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) 2015: the perfusionist (ccp) stated there were no issues during set-up and priming and for most of the cpb period.During the last minutes of cpb, when the patient was being weaned from cardiopulmonary bypass, the flow display on the sarns centrifugal unit was displayed as 0.00.The ccp stated the motor continued to work and there were clinical indications that there was blood flow in the circuit and patient.The ccp disconnected the sensor from the tubing and placed some ultrasonic gel on the sensor and re-connected the sensor to the tubing.The flow continued to be displayed as 0.00.The ccp disconnected the flow sensor from the control module and re-connected the sensor and 0.00 continued to be displayed.The ccp weaned the patient off cpb without difficulty.While off cpb, the ccp found an older level sensor in storage and connected the sensor to the control module and with the motor off and lines clamped the sensor was reading very erratic flows (according to the ccp bouncing all over) even though there was no actual flow.The control module and sensors were removed from service and the manufacturer was notified.The case was completed successfully with no delay and no associated blood loss.There was no harm observed.

Manufacturer Narrative

The field service representative (fsr) was unable to verify the complaint, while testing the flow sensors.The fsr performed functional and release test on the control module and flow sensors.The flow signal strength checked good on both flow sensors.The fsr ran the centrifugal unit with a test loop for 30 minutes and flow reading was steady.The control module and flow sensors operated to manufacturer specifications and was returned to clinical use.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: SARNS 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: 4479955
• MDR Text Key: 20124539
• Report Number: 1828100-2015-00025
• 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: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• 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