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

Catalog Number 397002-001

Device Problems Device Stops Intermittently (1599); 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 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and 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.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.During investigation testing, a malfunction of the manual pressure regulator to maintain the required pressure set point value was identified as the root cause of the customer-reported compressor cycling while the driver was connected to wall air.The issue of compressor cycling because of a malfunction of the manual pressure regulator 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 compressor cycling because of a malfunction of the manual pressure regulator.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and 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.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6221957
• MDR Text Key: 64182454
• Report Number: 3003761017-2016-00414
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• 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: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2013
• 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: 54 YR