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

Model Number 397002-001

Device Problems Image Display Error/Artifact (1304); Low Readings (2460)

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

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

The syncardia clinical support specialist on site at the time of the event ((b)(6) 2016) reviewed the alarm history of the companion 2 driver and confirmed a very low right and left cardiac output alarm and then a very low left cardiac output with cardiac output imbalance (high) alarm, which is consistent with a kinked driveline.The syncardia clinical support specialist performed a system check on the companion 2 driver and it passed all requirements.The syncardia clinical support specialist spoke with the attending physician on 09/28/2016 who stated that he believed the drivelines were kinked at the time.The physician stated that he had seen this event with a previous patient.The vad coordinator requested on 10/11/2016 that the companion 2 driver be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer reported that the patient was taken for a swallow test while supported by the companion 2 driver.The customer also reported that the displayed blood flows on the left side went to 0 while the displayed blood flow on the right side was 5.The nursing staff reported that they checked the drivelines and did not see a kink, but the patient was "crunched up" at the time and they looked for the kink after the patient lied down flat.The customer also reported that the patient was switched to a backup companion 2 driver without any reported adverse patient impact.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.The drop in left cardiac output and fill volumes as reported by the customer was reproduced during investigation testing.The root cause of this issue was identified as a malfunction of the pilot valves.Syncardia has an open capa (corrective and preventative action) to document the potential root cause and corrective actions associated with this issue.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 the patient was taken for a swallow test while supported by the companion 2 driver.The customer also reported that the displayed blood flows on the left side went to 0 while the displayed blood flow on the right side was 5.The nursing staff reported that they checked the drivelines and did not see a kink, but the patient was "crunched up" at the time and they looked for the kink after the patient lied down flat.The customer also reported that the patient was switched to a backup companion 2 driver without any reported adverse patient impact.

• 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: 6052473
• MDR Text Key: 58614870
• Report Number: 3003761017-2016-00332
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• 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: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• 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: 18 YR