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 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) 500101-001 500101 manufactured by Syncardia Systems, Llc.
[181547499]
The cpc connector is still supporting the patient and has not been returned to syncardia for evaluation. The customer reported that hospital personnel did not know how to change out a cpc connector so advanced training for the hospital personnel is being planned by the syncardia sales and clinical teams. 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. If new or additional information is received in the future, syncardia will file a follow-up mdr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181547500]
The customer, a syncardia certified hospital, reported that when a patient's wife tried to switch her husband to a backup driver due to a fault alarm (mfr report # 3003761017-2020-00071), the metal part of the cpc connector would not push down or come apart. Therefore, it was decided that the patient needed to come to the hospital via ambulance to have the connection site assessed and be switched to a backup driver. The customer reported that when the patient arrived at the hospital, he was switched to a companion 2 driver. The customer also reported it was a bit difficult to detach the red driveline from the red cannula due to what seemed to be grainy material inside of the cpc connector. The customer reported that hospital personnel did not know how to replace the cpc connector but were able to force the cpc connector open and dislodge a grainy material from the connector. The customer also reported that the cpc connector subsequently worked fine after the grainy material was removed. No additional information on the grainy material is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00073 |
| MDR Report Key | 9759390 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-02-09 |
| 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 |
| 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 | 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 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) |
| Generic Name | BIVENTRICULAR REPLACEMENT DEVICE |
| Product Code | LOZ |
| Date Received | 2020-02-26 |
| Model Number | 500101-001 |
| Catalog Number | 500101 |
| Lot Number | 119223 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |