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

Catalog Number 397002-001

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The syncardia clinical support specialist reported that the companion 2 driver exhibited an emergency battery alarm despite being connected to the wall power for 4 consecutive days at (b)(6).This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The syncardia clinical support specialist reported that the companion 2 driver exhibited an emergency battery alarm despite being connected to the wall power for 4 consecutive days at the (b)64).The companion 2 driver was returned to syncardia for evaluation.The patient file was copied and reviewed, revealing one emergency battery error alarm and five emergency battery low alarms.A visual inspection of the internal components revealed no anomalies.During investigation testing, efforts to reproduce the customer-reported emergency battery having a low state of charge were unsuccessful.A review of the emergency battery's history event data revealed no permanent faults or anomalies that could be attributed to the reported emergency battery having a low state of charge.The probable root cause for driver s/n (b)(4) to exhibit a low state of charge for the emergency battery is that the companion 2 driver was not properly plugged into an active ac wall power during storage and/or shipping, which allowed emergency battery s/n (b)(4) to become deeply discharged.In a state of deep discharge, the emergency battery's firmware enters into its low charge recovery mode (zvchg mode).Zvchg charging does not draw sufficient power for the driver's firmware to acknowledge that it is charging and will cause an emergency battery error message to be displayed and enunciated on the driver.In extreme cases, it can take longer than the recommended one hour charge period for the emergency battery to fully recover.The companion 2 driver was not supporting a patient at the time of the customer-reported issue and, therefore, there was no patient impact.If driver was supporting a patient, an emergency battery with a low state of charge would pose a low risk to a patient because the driver would continue 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 stopped powering the driver.The companion 2 driver system operator manual - english ous, section 12.10, states that the driver should always be connected to an active wall outlet at any time in order to conserve battery power.In addition, the operator manual instructs hospital personnel to complete the companion 2 driver system check upon receipt, prior to use, and every six months if the driver is not in use.The system check verifies that the driver can operate on the emergency battery and that the display and audible alarms are functioning as intended.During investigation and subsequent service, with no replacement of the emergency battery, the companion 2 driver passed all functional and performance testing before being placed into finished goods 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: 5243021
• MDR Text Key: 32160108
• Report Number: 3003761017-2015-00397
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

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: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2012
• 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