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

Model Number 397002-001

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the companion 2 driver did not display a right flow waveform and exhibited alarms, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia authorized distributor, reported that the companion 2 driver did not display a right flow waveform, exhibited several right pressure alarms and made an unusual pumping noise.The customer also reported that the patient was switched to a backup companion 2 driver with no reported adverse patient impact due to the driver exchange.

Manufacturer Narrative

The electronic patient data were reviewed and confirmed the customer-reported issue of right pressure alarms.During investigation testing, right overpressure and left pressure incorrect alarms were reproduced and the root cause was determined to be a malfunction of the right and left electronic pressure regulators.Syncardia has a corrective and preventive action (capa) for issues with electronic pressure regulators in relation to pressure alarms.The customer-reported strange pumping noise and loss of right flow waveform were not able to be confirmed, reproduced or observed during investigation testing.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7625135
• MDR Text Key: 112462575
• Report Number: 3003761017-2018-00233
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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: 06/11/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR