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

Catalog Number 397002-001

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

The companion 2 driver was not in use by a patient.The customer reported that when the companion 2 driver was docked in a companion 2 driver hospital cart, the driver touchscreen display worked but did not communicate with the hospital cart.The companion 2 driver was switched to another hospital cart and the same issue occurred.The companion 2 driver passed a system checkout in a companion driver caddy.This alleged failure mode poses a low risk to the patient, because the issue was observed when the companion 2 driver was not supporting a patient.In addition, the reported issue would not prevent the companion 2 driver from performing its life-sustaining functions.The companion driver has redundant, alternate power sources of external batteries and wall power.

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: CIRCULATORY ASSISTANT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq. vp ; 1992 e. silverlake road; ce 2386; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4296351
• MDR Text Key: 5271199
• Report Number: 3003761017-2014-00212
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2011
• 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