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

Model Number 397002-001

Device Problems Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Edema (2020)

Event Date 09/24/2017

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver is not being returned to syncardia for evaluation as there is no device malfunction.The driver performed as intended.Companion 2 driver system operator manual, section 8.2.5 optimization of adjustments contains a caution statement indicating that the left and right fill volume high alarms will not occur when the companion 2 driver is being used with the 50 cc tah-t.Further, the caution statement indicates that the fill volumes for the 50 cc tah-t should be monitored and driver settings adjusted if the patient is experiencing or approaching a full fill condition greater than 40 cc.The manual states that for a 50 cc patient, acceptable fill volumes should be between 30 cc and 40 cc.Companion 2 driver system training presentation, slide 30, states "the left/right fill volume high alarms are designed to trigger when fill volume exceeds 65 ml and therefore will not occur when the companion 2 driver is being used with the 50 cc tah-t".In addition, slide 30 of the presentation states "50 cc tah-t fill volumes should be monitored and driver settings may be adjusted if the patient is experiencing or approaching a full filling condition (40-50 ml)".Syncardia will provide addition information in a follow-up mdr as it becomes available.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient, a 50 cc tah-t pediatric study subject, was initially weaned from the ventilator on (b)(6) 2017, 1 day post-implant.The customer also reported that the patient was re-intubated after having a pulmonary episode.The customer also reported that the patient was again extubated on (b)(6) 2017.The customer expressed concern that there are no high fill volume alarms on the companion 2 driver to alert the staff of the subject's high fill volumes on 50 cc tah-t support.It was reported that the lack of this alarm was seen to have possibly contributed to the pulmonary edema and re-intubation that was experienced by the subject.The staff indicated that an alarm may have alerted the staff prior to the subject's full filling of the 50 cc tah-t.The customer also reported that the patient remains on companion 2 driver s/n (b)(4) since implant.

Manufacturer Narrative

Syncardia clinical specialist has discussed and retrained hospital staff on the companion 2 driver in reference to the 50cc tah-t, and that the companion 2 driver does not alert the staff of high fill volumes for the 50cc tah-t.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• 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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6973010
• MDR Text Key: 90087835
• Report Number: 3003761017-2017-00195
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 17 YR