MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART

Device Problems Product Quality Problem (1506); Shipping Damage or Problem (1570); Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/30/2021

Event Type  Injury  

Event Description

Patient is implanted with a syncardia 70cc temporary total artificial heart.He was discharged from the hospital on the freedom driver.However, was listed at status 2 on the unos transplant list for heart transplantation.We maintain 2 c2 drivers at the hospital because patient must be on c2 driver if hemodynamically unstable (e.G.For readmission or heart transplantation).On monday, (b)(6) 2021, we contacted syncardia requesting another c2 driver be sent due to a "system malfunction" alarm while performing a periodic check.After following up, it appears driver was not sent out until wednesday and we were informed driver wouldn't arrive until thursday.I was sent tracking information by the company for a different box not containing the driver.We received a heart offer for the patient on thursday but did not have a working driver at that time on thursday night.We again contacted the company to locate the driver that never arrived, and syncardia was able to locate the delayed shipment and have the driver arrive friday.Friday morning (b)(6) 2021), the driver arrived but alarmed when functional check was performed.At this point, we had one c2 driver which passed functional check but no backup unit for the patient.Patient needed procedure to prepare for heart transplant, so he needed to be on c2 driver for possible hemodynamic changes.Patient was switched to working c2 driver, which alarmed within ~30 seconds of providing support to the patient.At this point, patient was switched back to freedom driver (indicated for a hemodynamically stable patient).About 6 hours later, patient became hemodynamically stable and we had no working c2 driver to use for patient.Patient was supported on iv medication to attempt to stabilize while other drivers were in route.Two more c2 drivers were requested from syncardia in (b)(6) to our center in (b)(6).We were informed that they had "2 drivers" in (b)(6) which could be shipped out.They arrived on saturday @ 14:05 and passed functional checks.Patient was unstable for ~18 hours before working drivers could arrive.We had previously requested 3 c2 drivers in our center because of the high frequency of drivers not working appropriately.However, syncardia had requested one of these 3 drivers be sent back because it needed to be serviced.On monday morning, we were informed "the company is with new owners and increased business without increase in manufacturing.It is being addressed." we are highly concerned with the lack of appropriately functioning c2 drivers that syncardia has been able to provide over the last few months.This has affected patient safety this last weekend.Fda safety report id # (b)(4).

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; tucson AZ 85713
• MDR Report Key: 12280623
• MDR Text Key: 265406038
• Report Number: MW5103009
• Device Sequence Number: 4
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/02/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 85