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

Catalog Number 595000-001

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a pt.The pt subsequently switched to the backup freedom driver.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because although the freedom driver exhibited a fault alarm, the 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 supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The patient subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's exterior components revealed split housings at the top of the driver.Visual inspection of the driver's internal components revealed: raised boss insert, fractured housing bosses, damaged main piston cylinder board assembly (pcba) with broken u21 pressure sensor, abrasion on the primary motor.The damage observed to the driver is known to occur as a result of the driver experiencing an impact shock.During investigational testing, the fault alarm sounded approximately fifteen minutes upon startup.Despite the fault alarm that sounded during investigational testing, the driver passed all pressure testing requirements at nominal normotensive and hypertensive settings.The customer-reported fault alarm was duplicated.The root cause of the fault alarm experienced by the customer was the broken u21 pressure sensor on the main pcba, which was also confirmed by the alarm history (eeprom).Review of the alarm history (eeprom) revealed "right drive pressure too low for long enough to be permanent time-out." the driver housings, pca, pcba and motor/gearbox assemblies were replaced and the driver passed all final performance testing.This failure mode posed a low risk to the patient, because it did not prevent the freedom driver from performing its life-sustaining functions.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.

• Brand Name: FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4919604
• MDR Text Key: 6012623
• Report Number: 3003761017-2015-00215
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/17/2015

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: Other Health Care Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 22 YR