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

Model Number 397002-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver had a system malfunction alarm when the physician adjusted the vacuums from -8 to -7.The patient was switched to a backup driver and shortly thereafter was switched back to the original companion 2 driver.There were no alarms on the driver.There were no negative effects on the patient throughout the alarm notifications and the switching between drivers.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed a system malfunction alarm; however, no alarms related to the driver's vacuums were recorded.Additionally, review of the alarm data revealed that the alarm was triggered by fault code 35: timed out waiting for other embedded supervisor to agree on power down.The driver passed all functional testing and attempts to reproduce the system malfunction alarm through normal driver operation were unsuccessful.The driver performed as intended, no alarms sounded and there was no evidence of a device malfunction.Visual inspection of the external components revealed that the key was bent within the key switch.Additional manipulation of the key switch proved that a system malfunction alarm can be recorded if the key switch is improperly or incompletely turned.Due to the observed damage to and around the key switch, it is likely that the key switch was bumped causing the system malfunction alarm.Despite this alarm, the driver continued to provide its life sustaining function.The likely root cause of the customer-reported alarm was improper use, as the key was left in the key switch during patient support.The syncardia companion 2 driver system operator manual (c2-900002-fr) section 6.3 states: "when the driver is on, the key must be removed from the driver to prevent unintended interruptions to driver operation.Once removed, the key may be stored in a location determined by the clinical staff." section 12.9 and section 15.2.5 of the operator manual also state: "remove the key from the key switch when the driver is in operation.The key cannot be removed when the driver is switched off" and "remove the key from the key switch when the driver is in operation.The key cannot be removed when the driver is switched off", respectively.Each key for the companion 2 driver also has a red tag attached that includes instructions to remove the key while the driver is on.Syncardia has a corrective and preventive action (capa) to address and prevent incidents involving keys being left in the companion 2 driver that could possibly lead to an accidental driver shutdown.Syncardia has completed its evaluation and is closing this file.Ce (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az AZ 85713
• MDR Report Key: 9607183
• MDR Text Key: 175899924
• Report Number: 3003761017-2020-00026
• 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
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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: 02/04/2020
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR