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 2020-02-26 for SYNCARDIA FREEDOM DRIVER 595000-001 manufactured by Syncardia Systems, Llc.
[181546055]
The freedom driver has been returned to syncardia for evaluation. The results of the investigation will be provided in a follow-up mdr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181546056]
The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient. The customer also reported that the patient had coughed a few times over night and had a high pressure alarm sound that quickly cleared. However, in the morning he simply coughed for a second and the alarm went off and was unable to be cleared. The customer also reported that the patient was a dialysis patient and it was assumed that the alarm was from high fill volumes, however, the patient was dialyzed the last 2 days in the hospital and his fill volumes were in the 40's that day. The customer reported that the patient was switched to a backup driver. There was no reported adverse patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00074 |
| MDR Report Key | 9759382 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 595000-001 |
| Catalog Number | 595000-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-26 |