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

Model Number 595000-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a beat rate drift, it 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 freedom driver exhibited a beat rate drift while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed split and broken housings, broken top/left housing boss, raised insert and fractured bottom/right housing boss, impact damage to main printed circuit board assembly (pcba) and primary motor, broken bottom piston cylinder assembly (pca) pressure sensor connector, bent leads on u22 pressure sensor on main pcba, broken u21 pressure sensor on main pcba, and disconnected ribbon cable from speaker j2 connector.The customer-reported issue of "heart frequency" going up and down could not be confirmed as the driver exhibited a steady beat rate throughout investigation testing.The customer-reported issue of "different pump noises" was confirmed.The broken bottom pca pressure sensor connector was leaking air, and this noise was heard during investigation testing.External and internal visual inspections indicated that the driver was subjected to severe impact shock and rough handling, which was most likely the root cause for the broken bottom pca pressure sensor connector.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.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a beat rate drift and unusual noise while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6264802
• MDR Text Key: 65582698
• Report Number: 3003761017-2017-00022
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

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: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2012
• 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: 34 YR