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

Model Number 397002-001

Device Problems Filling Problem (1233); Device Operates Differently Than Expected (2913); Output below Specifications (3004)

Patient Problems Hypervolemia (2664); Patient Problem/Medical Problem (2688)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that after the patient had returned from a walk, the companion 2 driver exhibited decreased fill volumes and cardiac output.The customer also reported that the companion 2 driver had displayed diastolic waveform delay for at least a week but unclear for how long exactly.The staff had been changing the settings on the driver and did not prescribe diuretics as they reported that they thought the patient was drying out.The customer also reported that the patient was then switched to a back-up companion 2 driver and it was noted that the fill volumes were significantly higher.The staff again changed the driver settings and prescribed diuretics for the patient.The customer also reported that over the next few days the patient showed symptoms of moderate volume overload but continued to improve and was walking around the unit.

Manufacturer Narrative

The electronic patient data were reviewed and confirmed the customer-reported issue.During investigation testing, the diastolic waveform delay and decreased cardiac outputs were reproduced and the root cause was determined to be a malfunction of the pilot valves.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

Manufacturer Narrative

Corrected data section h1 ce 4305 follow-up report 2.

• 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
• MDR Report Key: 7560517
• MDR Text Key: 109828970
• Report Number: 3003761017-2018-00201
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• 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: 05/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR