MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOME AC POWER SUPPLY

Catalog Number 295600-002

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the reported issue would not prevent the freedom driver from performing its life-sustaining functions.Patients are supplied with a backup ac power supply and multiple onboard batteries.The freedom home ac power supply eu has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom home ac power supply eu is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified distributor, reported that the freedom home ac power supply eu was connected to the patient's freedom driver when the driver exhibited a low battery alarm.The customer also reported that the hospital staff noticed that the led on the ac power supply was not on and switched the patient to a backup ac power supply.The customer also reported that the onboard batteries in the freedom driver charged normally after the backup ac power supply was connected to the driver.There was no reported adverse impact on the patient.

Manufacturer Narrative

The freedom home ac power supply eu was returned to syncardia for evaluation.Investigation testing confirmed the customer-reported issue and verified that the home ac power supply eu had an internal electrical problem that disabled the unit from illuminating leds and outputting a voltage.However, because the freedom home ac power supply eu is an off-the-shelf component, no further mechanical disassembly or electrical diagnostic tests were performed by syncardia.The unit will be returned to the supplier for root cause analysis.The results of the supplier evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom home ac power supply eu is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified distributor, reported that the freedom home ac power supply eu was connected to the patient's freedom driver when the driver exhibited a low battery alarm.The customer also reported that the hospital staff noticed that the led on the ac power supply was not on and switched the patient to a backup ac power supply.The customer also reported that the onboard batteries in the freedom driver charged normally after the backup ac power supply was connected to the driver.There was no reported adverse impact on the patient.

Manufacturer Narrative

The freedom home ac power supply eu was returned to the supplier for root cause analysis.Internal visual inspection revealed that one of the l3 leads was broken.Closer examination showed that the l3 leads was in the through hole, but insufficient rtv silicone was used to secure the inductor in place to prevent shock or mechanical vibrations which caused the lead to break.The device malfunction was workmanship related.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 2.

Event Description

The freedom home ac power supply eu is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified distributor, reported that the freedom home ac power supply eu was connected to the patient's freedom driver when the driver exhibited a low battery alarm.The customer also reported that the hospital staff noticed that the led on the ac power supply was not on and switched the patient to a backup ac power supply.The customer also reported that the onboard batteries in the freedom driver charged normally after the backup ac power supply was connected to the driver.There was no reported adverse impact on the patient.

• Brand Name: SYNCARDIA FREEDOM HOME AC POWER SUPPLY
• Type of Device: FREEDOM HOME AC POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6360216
• MDR Text Key: 68758875
• Report Number: 3003761017-2017-00039
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295600-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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: 42 YR