MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CSS CONSOLE; EXTERNAL PNEUMATIC DRIVER

Catalog Number 400207

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient was switched from a freedom driver, to this css console during a clinical visit.The customer also reported that after the patient was switched to the css console, the fill volume of the left ventricle (lv) was in the 50's and the fill volume of the right ventricle (rv) was in the low 20's.The customer also reported that the patient was subsequently switched to a backup css console.There was no reported adverse patient impact.The customer also reported that following the css console switch, the vad coordinator tested this css console on a patient simulator.The customer reported that when the css console was connected to the patient simulator, the fill volume in the rv was lower than the fill volume in the lv.The reported issue posed a low risk to the patient because although the css console exhibited low right fill volumes, the css console continued to perform its life-sustaining functions.The css console will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4) follow-up report 1.

Event Description

The customer reported that the patient was switched from a freedom driver, to this css console during a clinical visit.The customer also reported that after the patient was switched to the css console, the fill volume of the left ventricle (lv) was in the 50's and the fill volume of the right ventricle (rv) was in the low 20's.The customer also reported that the patient was subsequently switched to a backup css console.There was no reported adverse patient impact.The customer also reported that following the css console switch, the vad coordinator tested this css console on a patient simulator.The customer reported that when the css console was connected to the patient simulator, the fill volume in the rv was lower than the fill volume in the lv.The css console was returned to syncardia for evaluation.Visual inspection of the css console's exterior components revealed no anomalies.The irregular right waveform failure reported in the field was duplicated at syncardia.After performing the incoming css console checkout, the validyne printed circuit board (pcb), which measures the amount of air flow exhausting from the controller into the drivelines, was found to be adjusted out of calibration.The out of calibration state changed the measurements and shape of the flow waveforms that were displayed on the software interface.This was the root cause of the customer-reported issue.Per the circulatory support system (css) and the software interface user's manual, the user is instructed to not operate or adjust the system without proper training or without complete knowledge of the contents of the user's manual.The investigation could not determine how the validyne pcb became out of calibration.The irregular right waveform was resolved at syncardia by recalibrating the validyne pcb.Typically, recalibration of the validyne pcb is not necessary, but it assists in bringing the waveforms into calibration.This failure mode poses a low risk to a patient because the css console would have continued to provide its life-sustaining functions.The displayed waveforms on the software interface are used for monitoring purposes.After calibration of the validyne pcb, the css console was serviced and passed all functional and performance testing before being placed into finished goods.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA CSS CONSOLE
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5147678
• MDR Text Key: 28660689
• Report Number: 3003761017-2015-00325
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400207
• Device Lot Number: 33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2014
• 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 Age: 57 YR