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

Model Number 6382

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) ordered a flow sensor and replaced it.At the time of replacement, the fsr was unable to duplicate the backflow on the flow sensor.No damage to the sensor was observed by the fsr.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during pre-cardiopulmonary bypass (cpb), there was a false backflow alarm on the perfusion system.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 20-may-2016: during the pre-cpb period, as the patient was being cannulated in preparation for cpb, the perfusionist (ccp) observed backflow alarms even though the cpb circuit was clamped off and isolated from the patient.The flashing flow display was indicating a backflow of 0.2-0.3 liters per minute (l/min).The ccp placed tubing clamps on both sides of the sensor and the backflow indication continued.The ccp moved the sensor to another site on the arterial line of the cpb circuit and the backflow indication continued.The ccp changed out the sensor with a replacement, and he had no other issues the remainder of the procedure.This did not delay the start of cpb and did not delay the procedure.The case was completed successfully without associated blood loss.

Manufacturer Narrative

After install of new part the field service representative (fsr) performed release test.The unit operated to manufacturer specifications and was returned to clinical use.

Manufacturer Narrative

The reported complaint was not confirmed.During laboratory evaluation, the sensor operated normally throughout the evaluation.The cover panel beneath the sensor¿s door was missing upon visual inspection.After proving the proper operation of a water loop circuit and flowmeter using lab-use only (luo) components, the device under test (dut) sensor was installed onto the (approximately six foot) loop.Within a perfusion screen, and with the centrifugal pump rotating, pump speed was adjusted throughout the entire range.Flow readings were displayed as normal throughout the typical range of zero to ten liters per minute (l/min).The product surveillance technician (pst) clamped off the tubing within 3¿ of dut sensor using a hemostat, both upstream and downstream.No backflow alarm was detected, even while manipulating (moving) the tubing.He stopped the rotation and removed clamp.The pst easily generated a "backflow" alarm by manipulating the tubing with no pump rotation.The same effect was obtained using a luo sensor and manipulation of the tubing.Again, the pst clamped off tubing over 36¿ (downstream) from sensor and could not get backflow alarm with dut or luo sensor.The dut flow sensor connector and cable were manipulated throughout the entire length while the test system was in operation with no issues found.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: 5694384
• MDR Text Key: 47603791
• Report Number: 1828100-2016-00385
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2012
• 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