MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

Model Number 293001-001

Device Problems Failure to Charge (1085); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external battery was not supporting a patient.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

This companion external battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion external battery would not charge after 24 hours in a companion 2 driver.

Manufacturer Narrative

The companion external battery was returned to syncardia for evaluation.Review of the system management (smbus) data revealed that the battery exhibited a safety over charge current (socc) permanent fault and its safety monitor had permanently disabled the input / output functions, confirming the customer-reported issues.The root cause for the device malfunction was determined to be that the battery was likely subjected to a deep discharge cycle with a prolonged duration prior to being recharged.When the battery was put into charge state, its safety circuitry disabled its output for exceeding firmware safety charge current limits.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.(b)(4) follow-up report 1.

Event Description

This companion external battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion external battery would not charge after 24 hours in a companion 2 driver.

• Brand Name: SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
• Type of Device: BATTERY PACK
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 6852803
• MDR Text Key: 85778406
• Report Number: 3003761017-2017-00163
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003077
• UDI-Public: (01)00858000003077
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/26/2017

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: 293001-001
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1