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

Model Number 595000-001

Device Problems Filling Problem (1233); Short Fill (1575); Device Displays Incorrect Message (2591)

Patient Problems Pulmonary Embolism (1498); No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  malfunction  

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) (mfr.3003791017-2018-00013) 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 (b)(4), 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 no new alarms were recorded.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.

• 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: 7167767
• MDR Text Key: 97723408
• Report Number: 3003761017-2018-00014
• 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
• Report Date: 06/25/2018

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?: No
• Is this a Product Problem Report?: Yes
• 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 Age: 25 YR