MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

Model Number 6382

Device Problem Invalid Sensing (2293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has ordered a replacement flow sensor.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor was not sensing flow.As a result, an alternate device was employed.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) 2016: according to the perfusionist (ccp), no issues with flow measurement were observed during prime and preparation of the cpb circuit.During cpb, a few backflow alarms were posted with no clinical evidence of backflow.The ccp also noticed the flow display was erratically changing from 1- 7 liters per minute (l/min) even though no changes in pump speed were made.The ccp disconnected the flow sensor from the control module and reconnected and the flow measurement appeared steady for about three to four minutes and then the erratic displays re-occurred.The ccp elected to take a flow sensor from an unused control module and he connected this new sensor to his system and the tubing.This mitigated the issue and flow sensing was steady for the remainder of the procedure.There were no issues with motor function or actual provided flow rates.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

Per follow-up with the perfusionist (ccp): the flow measurement issue observed was normally 1800 to 2000 revolutions per minute (rpm), was with tubing and was also clamped at the time of the issue; the flow measurements were running negative/positive erratic; the tubing clamp was located between the patient and the sensor; there was a flow sensor within the circuit and located between the pump and oxygenator (exit oxygenator to patient); and there was no damage noted to the flow sensor, it's cable or it's connector.Per follow-up with the field service representative (fsr) on 05-may-2016: he was told by the user facility¿s biomedical engineer (biomed) that it was an intermittent issue.The biomed replaced the flow sensor and he disposed of the faulty flow sensor.No part 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: SARNS CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5572974
• MDR Text Key: 43019175
• Report Number: 1828100-2016-00245
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2011
• 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