MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 397002-001

Device Problems Communication or Transmission Problem (2896); 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 07/20/2015

Event Type  malfunction  

Event Description

The customer reported that the companion 2 driver did not recognize wall air while supporting a pt.The customer also reported that the compressor ran sporadically.The customer changed the air hose and the pressure regulator without resolving the issue.The customer also reported that the pt was subsequently switched tot he backup companion 2 driver.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because it would not prevent the companion 2 driver from performing tis life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

A review of the driver's electronic patient file revealed numerous external air connected notifications.This was an indication that the necessary conditions required for the driver to operate exclusively on external air were not consistently met, thereby causing the driver to disable the external air connected icon and activate the primary compressor.This confirmed the customer-reported issue of the driver not recognizing external air.The root cause of the reported issue was that the main buffer pressure sensor voltage was out of the specified range, which indicated a malfunction of the manual pressure regulator.The manual pressure regulator was replaced and the driver passed all final performance testing.Despite the customer-reported issue of the driver not recognizing an external air source, risk to the patient was low because the driver continued performing its life-sustaining functions.Syncardia has initiated a corrective action (capa) to address the issue of manual pressure regulators unable to maintain specified set points.The investigation is in process.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: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ 85713
• Manufacturer Contact: carole marcot, esq ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4963991
• MDR Text Key: 23549222
• Report Number: 3003761017-2015-00244
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• 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?: Yes
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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
• Patient Age: 59 YR