MAUDE Adverse Event Report: SYNCARDIA SYSTEMS INC FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problems Incontinence (1928); Vomiting (2144); Weakness (2145); Loss of consciousness (2418)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Patient is on the freedom driver, 40 days on support and had a fault alarm during the night.At the time of the fault alarm, patient was on his bed working on his laptop and the freedom driver was inside the backpack plugged to the wall ac adaptor.According to the patient, the freedom driver was not dropped nor was there any visible damage to it.When it went to a fault alarm, there was no precursor to the event and the patient was able to only yell "help, help" before losing consciousness.The patient had a baby monitor inside the room so his parents and brother were able to hear his cry and the fault alarm.The patient's brother was the first one who arrived, within 5-10 seconds, to his bedroom and he had stated that the patient was unresponsive.The patient's parents got to the bedroom within 15 seconds with all the backup equipment with them.According to the patient's brother and parents they did not hear the freedom driver compressor/pump at all and said the only thing they heard was the fault alarm.Patient had his mouth open, flaccid, eyes open staring at the ceiling and was unresponsive.Patient also passed urine and stool during this time.Also, the patient's family had previously changed the patient to a backup freedom driver at home and the patient has been on the tah 70cc for over 1.5 years.They successfully switched the patient to the backup freedom driver in less than 2.5 minutes.Within 3 seconds of the change out, the patient became responsive again but according to the patient's family was disoriented for 2 minutes and immediately threw up.The last event he could recall was yelling "help, help" and initially stated upon regaining consciousness that his parents should change the freedom driver.Patient was reoriented to the post change out situation.Patient's family did not inform patient that the driver had stopped pumping and has requested that the patient not be informed of that the driver had stopped pumping.After patient was reoriented, the patient's mother called vad team representative and reported what had happened.Post change out driver parameters: 134 bpm fv 57 co 7.6.Bp normal in the 130s/70s.With a recheck bp of 120s/70s.After changing his clothes and bed linen, he was able to walk around his house within 10 minutes of the event.

• Brand Name: FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS INC; 1992 e. silverlake rd.; tucson, AZ 85713
• MDR Report Key: 4767813
• MDR Text Key: 5789369
• Report Number: 4767813
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2015
• Event Location: Other
• Date Report to Manufacturer: 05/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR