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

Catalog Number 295050-001

Device Problems Device Inoperable (1663); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

The customer reported that during a clinic visit the patient reported that the freedom ac power supply was not working.The customer also reported that the freedom ac power supply was switched without patient impact.This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing its life-sustaining functions.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00213) and (2) freedom battery charger s/n (b)(4) (mfr report # 3003761017-2015-00214).The customer reported that during a clinic visit the patient reported that the freedom ac power supply was not working.The customer also reported that the freedom ac power supply was switched without patient impact.The freedom ac power supply s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the freedom ac power supply revealed no abnormalities.Freedom ac power supply met all mechanical and functional requirements.The customer-reported issue could not be duplicated during testing.Freedom ac power supply was connected to a battery charger, which was loaded with four functional freedom onboard batteries with less than 20% capacity, and the charging system was capable of fully charging all four onboard batteries to full capacity.The ac power supply functioned as intended during investigation testing, and there was no evidence of a device malfunction.The customer-reported issue posed a low risk to the patient because it would not prevent the patient's freedom driver from performing its life-sustaining functions.Patients are provided with multiple onboard batteries, and the onboard batteries can also be charged in the freedom driver while it is connected to ac external power through the ac power supply or the car charger.Because freedom ac power supply s/n (b)(4) met all performance testing requirements, it was returned to 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 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: 4910078
• MDR Text Key: 6032997
• Report Number: 3003761017-2015-00213
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

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: Lay User/Patient
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: 68 YR