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

Model Number 595000-001

Device Problems Filling Problem (1233); Device Displays Incorrect Message (2591)

Patient Problems Pulmonary Embolism (1498); Fall (1848); Hematoma (1884); Patient Problem/Medical Problem (2688)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited low fill volumes and alarms, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be 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 certified hospital, reported that the patient fell in the shower at home and received a hematoma on his head.The customer also reported that freedom driver s/n (b)(4) supporting the patient exhibited low fill volumes and alarmed.The customer also reported that the patient was subsequently switched to a backup freedom driver without any patient impact.The customer also reported that freedom driver s/n 4638 (mfr.3003791017-2018-00014) now supporting the patient also exhibited low fill volumes and alarmed.The customer also reported that the patient was subsequently switched at the hospital to a companion 2 driver without any patient impact.The customer also reported that the companion 2 driver, now supporting the patient, also exhibited low fill volumes and tamponade waveforms.The customer also reported that the patient was subsequently diagnosed with a pulmonary embolism and was treated with tpa (anticoagulant).The customer also reported that the patient remains supported by the companion 2 driver.

Manufacturer Narrative

The driver alarm history was reviewed and revealed two alarm codes, 2d and 49.Since no signs of secondary motor engagement were observed during the investigation, the first alarm (code 2d) was likely produced at syncardia during the last servicing of the driver prior to shipment to the customer.The second alarm (code 49) is likely the customer-reported alarm as this alarm can be produced when the driver detects low cardiac output which corresponds with the customer-reported patient conditions.The driver in "as received" condition passed all functional test criteria.During additional investigation testing, the customer-reported low cardiac output alarm was reproduced by inducing high resistance on the right side of the tah-t.The root cause of the customer-reported low cardiac output alarm could not be conclusively determined; however, the customer reported a patient condition that would likely produce a low cardiac output alarm while the freedom driver was supporting the patient.The driver performed as intended and there was no evidence of a device malfunction.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.

Manufacturer Narrative

The driver alarm history was reviewed and revealed two alarm codes, 2d and 49.Since no signs of secondary motor engagement were observed during the investigation, the first alarm (code 2d) was likely produced at syncardia during the last servicing of the driver prior to shipment to the customer.The second alarm (code 49) is likely the customer-reported alarm as this alarm can be produced when the driver detects low cardiac output which corresponds with the customer-reported patient conditions.The driver in "as received" condition passed all functional test criteria.During additional investigation testing, the customer-reported low cardiac output alarm was reproduced by inducing high resistance on the right side of the tah-t.The root cause of the customer-reported low cardiac output alarm could not be conclusively determined; however, the customer reported a patient condition that would likely produce a low cardiac output alarm while the freedom driver was supporting the patient.The driver performed as intended and there was no evidence of a device malfunction.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.

Manufacturer Narrative

Ce 4075 follow-up report 2.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7167775
• MDR Text Key: 96488069
• Report Number: 3003761017-2018-00013
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR