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

Catalog Number 397002-001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

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

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited fill volume discrepancies while supporting a patient.The customer also reported that the companion 2 driver did not pass the system check.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 discrepancies in fill volume display, 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 evaluation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited fill volume discrepancies while supporting a patient.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The customer also reported that after the patient was switched to the backup driver, the companion 2 driver s/n (b)(4) did not pass the system check.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no anomalies.The patient electronic data were reviewed, which revealed the fill volume discrepancy and confirmed the system check failures as observed by the customer.During failure investigation testing, the customer-reported fill-volume discrepancy was reproduced.The root cause was a malfunction of the left and right main valve assemblies.The left and right main valve assemblies were replaced.The system check failures were indicative of malfunctions of the left and right electronic pressure regulators.As a result, the left and right electronic pressure regulators were replaced.These system check failures related to electronic pressure regulators are known issues that have been previously investigated is being investigated in a capa (corrective or preventive action).The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with malfunctions of the left and right electronic pressure regulators.This failure mode poses a low risk to the patient because although the companion 2 driver exhibited discrepancies in fill volume display, it did not prevent the driver from performing its life-sustaining functions.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: 5115520
• MDR Text Key: 27310168
• Report Number: 3003761017-2015-00320
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 09/25/2015

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: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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: 56 YR