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 2020-03-26 for SYNCARDIA FREEDOM DRIVER 595000-001 manufactured by Syncardia Systems, Llc.
[186718111]
The report from the hospital indicates the actions taken to resolve the freedom driver alarm were consistent with the information provided in the freedom driver system guidebook for patients and caregivers which refers to driveline kinks in several places including: glossary: a kink is caused when a driveline is bent resulting in decreased or no air flow through the driveline. Section 4. Warnings: caution box - 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. Do not allow the drivelines (or cannulae) to become kinked. If there is a fault alarm, immediately inspect the drivelines for kinks. Section 5. Precautions and recommendations caution box - 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. A sudden drop in cardiac output may be caused by a kink in the drivelines. Section 10. Additional information 10. 1. 1 things you should never do caution box - do not kink, twist, step on or place objects on drivelines or cannulae. This may cause loss of air that is necessary to pump your tah-t. Activities that may cause pulling, twisting or kinking of the cannulae or drivelines. This issue will continue to be monitored and trended as part of the customer experience process. Syncardia has completed is evaluation of this complaint and is closing this file. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186718112]
The customer, a syncardia certified hospital, reported that while pushing the patient into the hospital in her wheelchair, the patient lost consciousness and the freedom driver alarmed and showed **** on the display. The vad coordinator pushed past the paramedics who were around the wheelchair and she pulled the driveline to check that there were no kinks or disconnects. As she did this, the patient spontaneously awoke and was reported to be fine. The customer also reported that the freedom driver was performing as intended as the vad coordinator checked all the connectors and drivelines. It was not determined if the drivelines had become kinked while moving the patient into the er.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00096 |
| MDR Report Key | 9883785 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2017-10-16 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 5451234144 |
| 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 | 2020-03-26 |
| Returned To Mfg | 2020-03-18 |
| 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 | 1. Required No Informationntervention | 2020-03-26 |