MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problems Split (2537); Physical Property Issue (3008)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom onboard battery had a split housing, it did not prevent the freedom driver from performing its life-sustaining functions.Patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.The freedom onboard 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

The customer, a syncardia certified hospital, reported that a patient's freedom onboard battery had a split housing.The customer also reported that the patient's onboard battery was exchanged.There was no reported patient impact.

Manufacturer Narrative

The freedom onboard battery was returned to syncardia for evaluation.Visual inspection of the onboard battery revealed significant housing weld separation, j1 connector separation from the battery housing, as well as impact dents adjacent to the connector j1 connector, confirming the customer-reported issue.Functional testing was not performed on the onboard battery because of the significant physical damage observed during visual inspection.The root cause for the housing weld separation and the j1 connector housing separation and impact dents observed on onboard battery s/n (b)(4) was most likely impact shock.This type of damage is indicative of rough handling and/or mishandling.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

The customer, a syncardia certified hospital, reported that a patient's freedom onboard battery had a split housing.The customer also reported that the patient's onboard battery was exchanged.There was no reported patient impact.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael graippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6283173
• MDR Text Key: 66233313
• Report Number: 3003761017-2017-00028
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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: 23 YR