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

Catalog Number 295050-001

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/12/2016

Event Type  malfunction  

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 three separate medical device reports: freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2016-00092), freedom on board battery s/n (b)(4) (mfr report # 3003761017-2016-00093) and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00094).On (b)(6) 2016, the customer reported that the freedom driver exhibited a fault alarm while the patient was in the movie theater.The customer also reported that the driver was plugged in with a green light on the freedom power adaptor during the fault alarm.The customer also reported that when the patient was getting ready to leave the movie theater, they noticed that one of the freedom on board batteries had 2 bars and the other battery had 3 bars on the battery fuel gauge.The customer reported that the on board battery with 2 bars on the battery gauge was exchanged when the freedom driver faulted.The customer also reported that the patient was provided with a replacement ac power supply and onboard batteries.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 s/n (b)(4) will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up 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 three separate medical device reports: freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2016-00092), freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00093) and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00094).On (b)(6) 2016, the customer reported that the freedom driver exhibited a fault alarm while the patient was in the movie theater.The customer also reported that the driver was plugged in with a green light on the freedom power adaptor during the fault alarm.The customer also reported that when the patient was getting ready to leave the movie theater, they noticed that one of the freedom onboard batteries had 2 bars and the other battery had 3 bars on the battery fuel gauges.The customer reported that the onboard battery with 2 bars on the battery fuel gauge was exchanged when the freedom driver exhibited the fault alarm.The customer also reported that the patient was provided with a replacement ac power supply and onboard batteries.There was no reported adverse patient impact.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection revealed a broken strain relief on the cable and a missing o-ring on the connector.Despite this damage, the ac power supply passed all functional testing, which included testing to verify that the ac power supply could provide sufficient power to fully charge four freedom onboard batteries.The reported issue that the ac power supply was not able to charge onboard batteries was not confirmed or duplicated during the investigation.The ac power supply performed as intended, and there was no evidence of a malfunction.Because of the observed damage, the ac power supply was taken out of service.The reported issue 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 also has a redundant power source of onboard batteries.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: 5517859
• MDR Text Key: 41228816
• Report Number: 3003761017-2016-00092
• 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: 03/08/2016

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: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2015
• 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: 65 YR