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

Catalog Number 397002-001

Device Problems Loss of Power (1475); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 02/10/2018

Event Type  malfunction  

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 for clinical reasons the patient needed to be switched from the freedom driver to a companion 2 driver.The companion 2 driver was turned on and appeared to work fine, i.E.Screen came on and air heard through drivelines; however, when the drivelines were connected to the patient's cannulae, the companion 2 driver stopped working and the display showed "all the red alarms".The patient was immediately switched back to the freedom driver without any adverse impact.The customer also reported that the backup companion 2 driver was then powered on and the patient was switched to that companion 2 driver without any adverse impact.The patient remains in the same condition/stability as prior to the switch.

Event Description

The customer, a (b)(6) hospital, reported that for clinical reasons the patient needed to be switched from the freedom driver to a companion 2 driver.The companion 2 driver was turned on and appeared to work fine, i.E.Screen came on and air heard through drivelines; however, when the drivelines were connected to the patient's cannulae, the companion 2 driver "stopped working" and the display showed "all the red alarms".The patient was immediately switched back to the freedom driver without any adverse impact.The customer also reported that the companion 2 driver never stopped pumping and it alarmed very low left output.The customer also reported that the backup companion 2 driver was then powered on and the patient was switched to that companion 2 driver without any adverse impact.The patient remains in the same condition/stability as prior to the switch.

Manufacturer Narrative

Corrected data - additional information was provided by customer and added to field.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 red alarms and low left 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) for this issue.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4182 follow-up report 1.

• 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: 7302581
• MDR Text Key: 101476853
• Report Number: 3003761017-2018-00071
• 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
• Report Date: 02/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• 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: 02/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR