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

Model Number 595000-001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Volume Accuracy Problem (1675)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited fill volume readings that were outside the expected range, 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).

Event Description

The customer, a syncardia certified distributor, reported that the freedom driver exhibited fill volume readings that were outside the expected range 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 no abnormalities and the driver passed all functional testing.Extended observation testing confirmed that the driver remained within the fill volume (fv) requirements as permitted by freedom driver final test and acceptance procedure.There was no evidence of a device malfunction and the freedom driver performed as intended.The customer-reported experience of "wrong" fvs on the freedom driver could not be reproduced during investigation testing.The freedom driver's fvs were not compared to the fill volumes of a companion 2 driver, as the companion 2 driver settings and patient conditions at the time of the customer experience were not provided by the customer.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 distributor, reported that the freedom driver exhibited "wrong" fill volume readings while supporting a patient.The customer also reported that the displayed fill volumes on the freedom driver did not match the fill volumes displayed on a companion 2 driver when supporting the same patient.The customer also reported that this was the second freedom driver to have this reported issue while supporting the patient.[see freedom driver s/n (b)(4) (mfr.3003791017-2017-00043)].The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact and the issue was no longer observed.

• 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: 6370407
• MDR Text Key: 69152594
• Report Number: 3003761017-2017-00044
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2012
• 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: 53 YR