MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-18 for SYNCARDIA FREEDOM DRIVER 595000-001 manufactured by Syncardia Systems, Llc.
[188659533]
The freedom driver s/n (b)(4) will be returned to syncardia for evaluation. The results of the investigation will be provided in a follow-up mdr. Ce (b)(4) initial.
Patient Sequence No: 1, Text Type: N, H10
[188659534]
The customer, a syncardia certified hospital, reported that freedom driver s/n (b)(4)exhibited a fault alarm. When the hospital staff responded to the alarm, they noticed a burning metallic smell coming from the freedom driver s/n (b)(4). The customer reported the hospital staff attempted to change out the batteries (s/ns to follow), but were having some difficulty. During this time the freedom driver reportedly stopped. The customer also reported they switched the patient to her backup freedom driver s/n (b)(4). She was unconscious for approximately 90 seconds and was intubated. The customer also reported that a burning metallic smell was coming from the backup freedom driver s/n (b)(4) so they switched her to a companion 2 driver. There was no documentation of either driver being dropped or exposed to fluid. A ct scan of the patient's head was done which showed no acute abnormality. Neurology was consulted and noted that the patient was twitching (possible seizure activity) and that they were going to start her on keppra. The customer also reported that the patient was following commands, giving thumbs up and that she had equal strength bilaterally. The customer also provided an update on the patient indicating that she was extubated the evening of the reported freedom driver stoppage ((b)(6) 2020) and was reportedly intact neurologically. Following this episode, the patient had a headache that increased in severity and that was not resolved with treatment. On (b)(6) 2020, a ct of the head was done which showed subdural hematomas. Neuro assessments were done by the study neurologist. The crc at the site reported that there were no stroke-related deficits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00069 |
| MDR Report Key | 9722235 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-01 |
| Device Manufacturer Date | 2018-04-19 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KERRI HENSLEY |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Manufacturer Phone | 5451234120 |
| Manufacturer G1 | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCARDIA FREEDOM DRIVER |
| Generic Name | EXTERNAL PNEUMATIC DRIVER |
| Product Code | LOZ |
| Date Received | 2020-02-18 |
| Model Number | 595000-001 |
| Catalog Number | 595000-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Address | 1992 E. SILVERLAKE ROAD TUCSON, AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |