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

Catalog Number 397002-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Loss of consciousness (2418)

Event Date 01/08/2018

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) initial.

Event Description

The customer, a syncardia certified hospital, reported that when the companion 2 driver was moved around the patient's bed, it exhibited a system malfunction alarm.The customer also reported that the tah-t continued to pump audibly, fill volumes were consistent, blood pressure was stable and patient experienced no symptoms.The customer also reported that the driver power and air cords were unplugged and plugged back in, driver was lifted up out of base and returned with no resolution of alarms.Nurse was instructed to switch patient to backup driver.The customer also reported that during the switch the nurse couldn't get the drivelines connected to the new companion 2 driver (per patient's husband it took 5-6 seconds to make switch) and the patient lost consciousness but immediately returned to baseline following the switch.The customer also reported that patient was transplanted the next day.

Manufacturer Narrative

Visual inspection of the companion 2 driver revealed a scratch in the driver cover skin above the key switch and the key was bent within the key switch.The electronic patient data was reviewed and revealed a system malfunction alarm, thus confirming the customer-reported alarm.Attempts to reproduce the system malfunction alarm through normal driver operation were unsuccessful as the driver passed all functional testing with no anomalies or alarms.Additional testing was performed on the driver and determined that an improper/incomplete rotation of the key in the key switch will result in a system malfunction alarm.It is possible that while moving the driver around the patient's bed, as reported by the customer, the key could have been inadvertently bumped, resulting in both the physical damage observed during incoming inspection and the system malfunction alarm as observed by the customer.The likely root cause of the customer-reported alarm was improper use, as the key was left in the key switch during patient support.Hospitals are instruction to remove the key from the driver during patient support.The syncardia companion 2 driver system operator manual (c2-900005) 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.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.

Manufacturer Narrative

Corrected data section h1 ce 4122 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: 7227693
• MDR Text Key: 98574608
• Report Number: 3003761017-2018-00029
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 0085800003107
• UDI-Public: (01)0085800003107
• 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: 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: 01/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR