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

Model Number 397002-001

Device Problems Low Readings (2460); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); Low Cardiac Output (2501)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the companion 2 driver continued to perform 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.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited diagnostic waveform delay with decreased cardiac output while supporting a patient.The customer also reported that the patient was switched to a backup driver without any adverse patient impact.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.The customer-reported issues were reproduced during investigation testing; the driver exhibited delayed diastolic waveform timing and decreased cardiac output when connected to an external air source.The root cause was determined to be a malfunction of the left and right pilot valves.Syncardia has an open corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited diagnostic waveform delay with decreased cardiac output while supporting a patient.The customer also reported that the patient was switched to a backup driver without any 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: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6552713
• MDR Text Key: 74794932
• Report Number: 3003761017-2017-00073
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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