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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Patient Problem Loss of consciousness (2418)
Event Date 11/05/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2015, the customer reported that the freedom driver stopped without audible or visual alarms while the patient was in a car with his brother.The customer also reported that the freedom driver was plugged into the car charger with the vehicle running.The customer also reported that the patient briefly lost consciousness at the time of the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient promptly regained consciousness and felt fine after he was switched.On (b)(6) 2015, the customer reported that at the time of the event the batteries were exchanged not the freedom driver.Upon exchange of the batteries at the time of the event, the freedom driver immediately resumed pumping and the patient promptly regained consciousness.The patient was supported by the driver for approximately 40-45 minutes while being driven to the hospital by his brother where the patient was switched to the backup freedom driver with no adverse impact.The customer reported that the driver alarmed as expected during the exchange when the drivelines were disconnected.The patient was evaluated by hospital staff and allowed to go home the same evening of the event.The patient states that he is feeling fine.On (b)(6) 2015, the customer reported that the patient's brother, the driver of the vehicle at the time of the event, said that the freedom driver was not plugged into the car when the event occurred.The brother also stated that he had just parked the car, unplugged the patient from the car before exiting the vehicle and noticed when he looked back at the vehicle that his brother, the patient, was unconscious in the passenger side.He then got the extra batteries from the backpack and put them into the freedom driver, the freedom driver started up and the patient woke up.The patient continues to be supported by a freedom driver at home without any issues.The freedom driver, batteries and car charger have been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2015, the customer reported that the freedom driver stopped without audible or visual alarms while the patient was in a car with his brother.The customer also reported that the freedom driver was plugged into the car charger with the vehicle running.The customer also reported that the patient briefly lost consciousness at the time of the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient promptly regained consciousness and felt fine after he was switched.On (b)(6) 2015, the customer reported that at the time of the event the batteries were exchanged not the freedom driver.Upon exchange of the batteries at the time of the event, the freedom driver immediately resumed pumping and the patient promptly regained consciousness.The patient was supported by the driver for approximately 40-45 minutes while being driven to the hospital by his brother where the patient was switched to the backup freedom driver with no adverse impact.The customer reported that the driver alarmed as expected during the exchange when the drivelines were disconnected.The patient was evaluated by hospital staff and allowed to go home the same evening of the event.The patient states that he is feeling fine.On (b)(6) 2015, the customer reported that the patient's brother, the driver of the vehicle at the time of the event, said that the freedom driver was not plugged into the car when the event occurred.The brother also stated that he had just parked the car, unplugged the patient from the car before exiting the vehicle and noticed when he looked back at the vehicle that his brother, the patient, was unconscious in the passenger side.He then got the extra onboard batteries from the backpack and put them into the freedom driver, the freedom driver started up and the patient woke up.The patient continued to be supported by freedom driver at home without any issues.The patient was successfully transplanted on (b)(6) 2016.The freedom driver, onboard batteries and car charger were returned to syncardia for evaluation.A visual inspection of the freedom driver as received from the customer site revealed damage to the returned freedom driver (s/n (b)(4)): all four of the tamper prevention plugs, intended to prevent disassembly of the freedom driver chassis, were missing from their intended locations.An inspection of the freedom drivelines revealed heavy scuff marks, which are an indication of atypical abrasion wear.Upon disassembly of the freedom driver, a cracked boss was found on the interior wall of the driver housing.In addition, the hose connection clamp and associated screw and washer had detached from their original mounting point and had come to rest in the bottom of the housing.The eeprom data extracted from the driver indicated that no permanent fault alarm was associated with the reported customer experience.Testing was performed on each subcomponent of the freedom driver system that was reported to be in use at the time of this event, including freedom driver s/n (b)(4), two onboard batteries, a power adaptor and a car charger.Each subcomponent passed all functional tests with no performance anomalies observed.The reported customer experience could not be reproduced during the as-received performance evaluation of driver s/n (b)(4).Based on the results of the engineering analysis conducted as part of this investigation, the most probable cause for the reported customer experience is an interruption of electrical power from an electrical short, which resulted in a temporary stoppage of the freedom driver system.The investigation indicated that the driver had been subject to rough handling, most likely an impact shock.In an effort to mitigate the risks associated with driver damage from impact shock, a warning is included in both the freedom driver system operator manual, f-900013-en, and the freedom driver system patient and caregiver guidebook, f-900014-en.The labeling states that if the freedom driver or any of the accessories are dropped, they must be brought back to the hospital for replacement.An impact shock of sufficient force to crack a housing boss could also contribute to the loosening or detachment of internal hardware features and damage to the freedom drivelines.Loose hardware was found at the bottom of the freedom driver housing.An electrical short could have been caused by the loose internal hardware.The missing tamper prevention plugs from the external chassis of the driver are further evidence of improper handling of the driver.A warning is included in the instructions for use that accompany every freedom driver system prohibiting the opening of the back panel of the freedom driver and warning that no modification of this equipment should be performed by any clinician, caregiver or patient.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.
 
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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 Key5265449
MDR Text Key32869383
Report Number3003761017-2015-00386
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 11/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/05/2015
Initial Date FDA Received12/03/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 YR
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