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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Audible Prompt/Feedback Problem (4020)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

The customer, a syncardia certified hospital, reported that the patient was found unresponsive at home with freedom driver alarming for low cardiac output (mfr report # 3003761017-2020-00111).The patient's spouse switched him to a backup freedom driver which also displayed a fault alarm.The spouse called ems who administered lasix and epi at the residence and called life flight.The patient regained consciousness prior to transfer and was appropriately responding to commands.Once at the hospital, the patient was transitioned to a companion 2 driver without incident.The customer also reported that the patient was severely volume overloaded with a cardiac output of 9.0 l/min.After four days, the patient's cardiac output was down to 7.2 l/min and his blood pressure was in check.

Manufacturer Narrative

Visual inspection of the interior of the driver revealed metallic debris.The driver's alarm history was reviewed and revealed "2d" and "0f" alarm codes.These were most likely the alarms observed by the customer as they are produced when the secondary motor is engaged.The driver passed all sections of functional testing.In an attempt to reproduce the customer-reported alarm, the driver underwent a 48-hour observation run.During this test no alarms were observed, however, the driver made a squeaking noise.Investigation tested determined that the noise was caused by the primary motor / piston cylinder assembly (pca) where the dowel pin was carving a groove in the pca guide wall.This wearing away of the guide wall is also the source of the metallic debris that was found during visual inspection.It is suspected that this mechanical interference led to the driver switching to the secondary motor and annunciating the fault alarm that was experienced by the customer.Because there is evidence of operation of the secondary motor, the driver was also tested on the secondary system.The driver's secondary system operated as intended.The root cause of the customer-reported alarm was the egagment of the secondary motor due to the mechanical interference of the primary motor and pca.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5262 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: 9967842
• MDR Text Key: 202367899
• Report Number: 3003761017-2020-00112
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/17/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR