MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY

Catalog Number 295050-001

Device Problem Crack (1135)

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

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medial device reports: freedom ac power suppy s/n (b)(4) (mfr report # 3003761017-2016-00238 and freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2016-00243).The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that freedom ac power supply s/n (b)(4) has a cracked connector.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.The freedom driver has a redundant power source of onboard batteries.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).Fup 1 - 1 of 2.

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medial device reports: (1) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2016-00238 and (2) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2016-00243).The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that freedom ac power supply s/n (b)() had a cracked connector.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse impact.The ac power supply was returned to syncardia for evaluation.Visual inspection revealed scratches and a crack in the housing, a broken strain relief and a crack in the connector cover.During investigation testing, despite the observed damage, the ac power supply was electrically functional, would mate with a freedom power adaptor, and could provide power to a freedom driver.Housing scratches and broken strain relief usually occur from normal wear and tear.A cracked connector cover usually occurs from being dropped or stepped on.Because of the damage observed during the investigation, the ac power supply was taken out of service.This failure mode posed a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.The freedom driver has redundant power sources of onboard batteries and a car charger.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 FREEDOM AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• 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: 5738668
• MDR Text Key: 48717632
• Report Number: 3003761017-2016-00238
• 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: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2012
• 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
• Patient Age: 55 YR