MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 595000-001

Device Problem Device Inoperable (1663)

Patient Problems Fall (1848); Incontinence (1928); Loss of consciousness (2418)

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4), 1 of 5.

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under five separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00298, (2) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00299), (3) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00300), (4) freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2015-00305), and (5) freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2015-00306).The customer reported that while the patient was getting up to get something to eat, the freedom driver stopped working.The customer also reported that the patient lost consciousness, fell, and had an incontinent episode.The customer also reported that when the patient fell, he hit the freedom driver and damaged the driver's ac power supply and power adaptor.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.The freedom driver 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: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00298, (2) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00300), and (3) freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2015-00306).The customer reported that while the patient was getting up to get something to eat, the freedom driver stopped working.The customer also reported that the patient lost consciousness, fell, and had an incontinent episode.The customer also reported that when the patient fell, he hit the freedom driver and damaged the driver's ac power supply and power adaptor.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.The freedom driver was returned to syncardia for evaluation.Evidence suggested that the driver sustained a significant impact shock, causing damage to the primary motor attachment pins and resulting in the primary motor attachment pins making contact with the primary motor rotor.The evidence also suggested that the primary motor was operating prior to and after the impact shock, because visible rub marks from the motor pins were evident on the primary motor rotor.While there may have been a brief pause or slowing in pumping as a result of the motor pins contacting the primary motor rotor, there was no evidence to suggest that the driver stopped or reverted to secondary motor operation.The time-out fault alarm recorded in the electronic data may have been caused by a brief pause or brief slowing in pumping.However, the evidence suggested that this was consistent with the direct result of a significant impact shock to the driver and not the result of a device malfunction.The driver was serviced and included the replacement of the main printed circuit board assembly (pcba), housings, motor/gearbox assemblies, piston cylinder assembly (pca), motor pins and power adaptor, before being placed into 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 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• 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: 5091176
• MDR Text Key: 26567466
• Report Number: 3003761017-2015-00298
• 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: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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: 58 YR