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

Catalog Number 397002-001

Device Problems Device Alarm System (1012); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2015

Event Type  malfunction  

Event Description

The customer reported that the pt was placed on a companion 2 driver for a procedure.The customer also reported that companion 2 driver had not been plugged in prior to the procedure and that the external batteries and the emergency battery were drained.The customer reported that during the procedure, the companion 2 driver was placed in the operating room mode so no alarms were heard.The customer also reported that the external batteries were replaced without any adverse patient impact.This alleged failure mode poses a low risk to the pt because it did not prevent the companion 2 driver from performing its life-sustaining functions.In addition, the companion 2 driver has a redundant power source of external wall power.The companion 2 driver wil be returned to syncardia for investigation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient was placed on a companion 2 driver for a procedure.The customer also reported that companion 2 driver had not been plugged in prior to the procedure and that the external batteries and the emergency battery were drained.The customer reported that during the procedure, the companion 2 driver was placed in the operating room mode so no alarms were heard.The customer also reported that the external batteries were replaced without any adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.A review of the driver's electronic patient file revealed an emergency battery error alarm, which confirmed the customer experience of a depleted emergency battery.External battery error alarms were also observed.Since the customer reported that the initial batteries used were depleted, these alarms are not unusual.While in a severely depleted state, as a safety measure, the batteries would enter a pre-charge state.During this state, the batteries would only accept a trickle charge until they reach a certain threshold to recover and an external battery error would be in effect.Evaluation of the emergency battery determined that the emergency battery was fully functional and will not be replaced.The likely cause of the depleted emergency battery was a result of leaving the companion 2 driver unplugged for a long period of time.It is recommended to keep the driver plugged into an external power source at all times to maintain full battery charge.Testing was performed to determine if the driver could recognize and operate via external batteries.Multiple batteries were tested and functioned as intended with the driver.The original batteries used during the customer experience were not returned to syncardia.The companion 2 driver was supporting a patient at the time of the customer-reported issue.Depletion of the emergency battery poses a low risk to the patient because the driver continued to perform its life-sustaining functions.The emergency battery is one of four redundant power sources and is designed to be used only in the event that ac power and the two external batteries have been removed from the driver.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4987729
• MDR Text Key: 23437840
• Report Number: 3003761017-2015-00245
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Nurse
• Remedial Action: Replace
• Report Date: 07/23/2015

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: Nurse
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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: 47 YR