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

Catalog Number 397002-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pulmonary Edema (2020); Decreased Respiratory Rate (2485); Low Cardiac Output (2501); No Code Available (3191)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the companion 2 driver continued to perform its life-sustaining functions.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 the companion 2 driver exhibited diastolic waveform delay with decreased cardiac output while supporting the patient.The customer also reported the patient was subsequently switched to the backup companion 2 driver and the waveforms looked appropriate.The customer also reported that the patient had been supported by this companion 2 driver since tah-t implant on (b)(6) 2017 and had been in and out of the step down unit.The customer also reported that the patient had lung issues and respiratory distress prior to contracting a legionella infection around (b)(6) 2017.The customer also reported that the patient was very fluid overloaded and was undergoing dialysis three times per week.

Manufacturer Narrative

Corrected data updated.The companion 2 driver was returned to syncardia for evaluation.The patient data file was reviewed and revealed multiple alarms related to low cardiac output, thus confirming the decreased cardiac output reported by the customer.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 valve.Syncardia has a corrective and preventive action (capa) to address this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited diastolic waveform delay with decreased cardiac output while supporting the patient.The patient had been supported by this companion 2 driver since tah-t implant on (b)(6) 2017.While on tah-t support, he was in and out of the step-down unit.The customer also reported that the patient had developed respiratory dysfunction and distress prior to contracting a legionella infection around the (b)(6) 2017.The patient was very fluid overloaded and was undergoing dialysis three times per week.The patient was subsequently switched to the backup companion 2 driver and the waveforms looked appropriate.

• 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: 7229335
• MDR Text Key: 98628853
• Report Number: 3003761017-2018-00036
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 0085800003107
• UDI-Public: (01)0085800003107
• 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: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2017
• 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): Hospitalization
• Patient Age: 58 YR