MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper Flow or Infusion (2954)

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

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that when the patient was switched to this companion 2 driver the flows were off by 0.6 lpm +/- and the physician and nurses were not comfortable using the driver.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited different flows, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a followup mdr.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue of a discrepancy in cardiac outputs was confirmed through review of the patient file and reproduced during investigation testing.The root cause was determined to be a malfunction of the left mass flow sensor.This issue will continue to be trended and monitored 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 reported that when the patient was switched to this companion 2 driver the flows were off by 0.6 lpm +/- and the physician and nurses were not comfortable using the driver.

• Brand Name: SYNCARDIA COMPANION 2 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: 5928814
• MDR Text Key: 54551849
• Report Number: 3003761017-2016-00308
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

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: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• 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: 39 YR