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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

Patient Problem Loss of consciousness (2418)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be submitted in a follow-up mdr.(b)(4) - initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient was at the laundromat and while reaching in a dryer, dropped the freedom driver.The driver stopped and the patient lost consciousness for "a few seconds" and then regained consciousness when the freedom driver restarted.The patient's wife then switched him to a backup driver and reported that "he was fine." the customer also reported that the patient was admitted to the hospital overnight and was discharged the next day.

Manufacturer Narrative

Visual inspection of the driver revealed physical damage to the front housing, the secondary motor out of bottom dead center (bdc), raised inserts in four housing inserts, and an rv1 potentiometer that was detached from the main printed circuit board assembly (pcba).The observed physical damage aligns with an impact shock to the driver, as was reported by the customer.Review of the alarm history identified one new recorded alarm, a 0f fault code indicating a bdc timeout.This fault code is consistent with the detached rv1 potentiometer.A detached rv1 potentiometer would cause the primary motor to stop, resulting in a bdc timeout and a transition to secondary motor operation as designed.The customer-reported stop and restart was partially reproduced as the driver switched to secondary motor operation upon startup.The driver was subjected to a functional evaluation under secondary motor operation and satisfied all pressure test requirements with no anomalies.The root cause of the driver stop and restart was determined to be the detachment of the rv1 potentiometer from the main pcba most likely caused by the reported impact shock (drop) to the driver, as reported by the customer and evidenced by the observed physical damage.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint 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: 8837620
• MDR Text Key: 152531157
• Report Number: 3003761017-2019-00223
• 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
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• 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: 07/03/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR