|
Catalog Number 595000-001 |
Device Problem
Device Displays Incorrect Message (2591)
|
Patient Problems
Death (1802); Loss of consciousness (2418)
|
Event Date 08/11/2016 |
Event Type
Death
|
Manufacturer Narrative
|
The freedom driver was returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) (1 of 3).
|
|
Event Description
|
The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00321, freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00341) and freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00342).The customer reported that, according to the patient's girlfriend, the patient and his roommate had to change out his freedom driver "multiple times" that morning.The girlfriend did not know what type of alarms nor how many times the freedom driver was exchanged, as she was not there at the time.The customer also reported that when hospital personnel spoke directly with the patient earlier in the day regarding lab results, he did not mention any freedom driver alarms or exchanges.The customer also reported that the patient was supplied with two backup freedom drivers, but was unsure which driver was supporting the patient at the beginning of the day.The customer also reported that, according to the girlfriend, who was not at the home during these events, the patient's (b)(6) year old son, who was not a trained caregiver, heard an alarm, then a crash.The son found his father lying on his stomach, but was unable to turn him over to check anything out.The son did not know what the alarm was and he did not know where the backup driver was located.The son called a neighbor that lived nearby for help, and then called the patient's caregiver who returned home, retrieved the backup driver and switched the patient.The customer also reported that this series of events lasted approximately 45 minutes and the patient was blue in color when the backup driver was connected and the ambulance arrived.The customer also reported that the patient was transported to a non-certified syncardia tah-t center hospital.A hospital representative reported to (b)(6) that to her knowledge, the patient arrived with a functioning driver but had expired.The hospital called the syncardia hotline because they were unfamiliar with the device and didn't know how to turn it off.
|
|
Manufacturer Narrative
|
The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed split housings, fractured display cover, and abrasions on the housings.Visual inspection of the internal components of the driver revealed fractured housing bosses with raised insert, severed black wire of the exhaust fan assembly, and abrasion on the primary motor and main printed circuit board assembly (pcba).Based on the damage observed during visual inspection, it is likely the driver was subjected to rough handling or an impact shock.The electronic data was reviewed and based on the information provided by the customer, the most likely root cause for the alarms recorded can be attributed to mishandling of the driver and onboard battery, which resulted in intermittent communication errors and a permanent fault condition.The driver in "as received" condition passed all functional pressure test requirements, which included cardiac output (co), right atrial pressure (rap), aortic pressure (aop), pulmonary arterial pressure (pap) and left atrial pressure (lap) performance metrics associated with normotensive and hypertensive settings, with no unintended alarms.The exhaust fan malfunction due to the severed wire would not prevent the driver from performing its life-sustaining functions.Patients and caregivers are instructed in the ifu and during the hands-on training by the hospital to immediately return any equipment that has been dropped.Freedom driver system guidebook for patients and caregivers section 4 warnings - caution failure to adhere to the warnings listed below may cause the freedom driver system to malfunction or not perform the life-sustaining functions as designed.Warning states "if the freedom driver or any of the accessories are dropped, bring them to your hospital for replacement." freedom driver system guidebook for patients and caregivers section 5 precautions and recommendations - caution failure to adhere to the precautions and recommendations listed below may cause the freedom driver system to malfunction or not perform the life-sustaining functions as designed.Recommendation states "it is strongly recommended to have two people exchange the primary freedom driver for the backup freedom driver.The customer reported that the patient was left without his caregiver.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.(b)(4) follow-up report 1 (1 of 3).
|
|
Event Description
|
The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00321, (2) freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00341) and (3) freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00342).The customer reported that, according to the patient's girlfriend, the patient and his roommate (unknown if person was a trained caregiver) had to change out his freedom driver "multiple times" that morning.The girlfriend did not know what type of alarms nor how many times the freedom driver was exchanged, as she was not there at the time.The customer also reported that when hospital personnel spoke directly with the patient earlier in the day regarding lab results, he did not mention any freedom driver alarms or exchanges.The customer also reported that the patient was supplied with two backup freedom drivers, but was unsure which driver was supporting the patient at the beginning of the day.The customer also reported that, according to the girlfriend, who was not at the home during these events, the patient's (b)(6) son, who was the only person with the patient and not a trained caregiver, heard an alarm and then a noise and found the patient lying on his stomach.The son did not know what the alarm was and he did not know where the backup driver was located.The son called a neighbor that lived nearby for help, and then called the patient's caregiver who returned home, retrieved the backup driver and switched the patient.The customer also reported that this series of events lasted approximately 45 minutes before the ambulance arrived.The patient was transported to a non-certified syncardia tah-t center hospital.A hospital representative reported to (b)(6) that to her knowledge, the patient arrived with a functioning driver but had expired.The hospital called the syncardia hotline because they were unfamiliar with the device and didn't know how to turn it off.
|
|
Search Alerts/Recalls
|
|
|