MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397002-001

Device Problems Device Displays Incorrect Message (2591); Power Problem (3010)

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

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited irregular left driving pressure (ldp) waveforms when connected to the external wall air while supporting a patient.The customer also reported that the ldp varied from 165 to 255 when it was set at 210.The ldp was less irregular at 205 to 210 when the companion 2 driver was disconnected from the external wall air and the driver was running on internal compressors.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited irregular left pressure waveforms, it did not prevent the driver from performing its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

Ce 3010 follow-up report 1.

Event Description

The customer reported that the companion 2 driver exhibited irregular left driving pressure (ldp) waveforms when connected to the external wall air while supporting a patient.The customer also reported that the ldp varied from 165 to 255 when it was set at 210.The ldp was less irregular at 205 to 210 when the companion 2 driver was disconnected from the external wall air and the driver was running on internal compressors.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's internal components revealed no anomalies.The patient file was copied and reviewed, which revealed multiple left pressure incorrect alarms.Review of the patient file extended data confirmed the customer-reported fluctuation of left driveline pressure readings.During investigation testing, the fluctuation of the left driveline pressure was duplicated.The root cause was a malfunction of the left electronic pressure regulator.Despite the customer-reported fluctuation of left driveline pressure readings, risk to the patient was low because the driver continued to perform its life-sustaining functions.Review of the extended data confirmed that the driver did not induce full filling of the ventricles and that full ejection was present.After the left electronic pressure regulator was replaced, the companion 2 driver was serviced and passed all 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 COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): 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: 5171729
• MDR Text Key: 29357942
• Report Number: 3003761017-2015-00363
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

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: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 10/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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: 15 YR