MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 595000-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Program or Algorithm Execution Problem (4033)

Patient Problem Hypervolemia (2664)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The customer, a syncardia certified hospital, reported that the patient was placed on this freedom driver on (b)(6) 2022.Throughout his time at home, the patient felt well.He came in for a clinic visit on (b)(6) 2022 and his total bilirubin and creatinine was measured and indicated an increase over baseline pointing to a possible fluid overload condition.A transesophageal echocardiogram was performed which showed that his right atrium was dilated thus confirming a fluid overload patient condition.The patient was admitted, switched to a companion 2 driver and medical treatment was administered to decrease his fluid overload condition.The customer also reported the patient's fluid status returned to normal range and he was transitioned back to a freedom driver.The patient was discharged home (b)(6) 2022 and has subsequently been seen in the clinic as part of his normal care and was doing well.The customer also reported that the fill volume numbers were not the same on the companion 2 driver as compared to the freedom driver when supporting the patient.The hospital did not think the freedom driver fill volumes were reading correctly.

Event Description

The customer, a (b)(6) hospital, reported that the patient was placed on this freedom driver on (b)(6) 2022.Throughout his time at home, the patient felt well.He came in for a clinic visit on (b)(6) 2022 and his total bilirubin and creatinine was measured and indicated an increase over baseline pointing to a possible fluid overload condition.A transesophageal echocardiogram was performed which showed that his right atrium was dilated thus confirming a fluid overload patient condition.The patient was admitted, switched to a companion 2 driver and medical treatment was administered to decrease his fluid overload condition.The customer also reported the patient's fluid status returned to normal range and he was transitioned back to a freedom driver.The patient was discharged home (b)(6) 2022 and has subsequently been seen in the clinic as part of his normal care and was doing well.The customer also reported that the fill volume numbers were not the same on the companion 2 driver as compared to the freedom driver when supporting the patient.The hospital did not think the freedom driver fill volumes were reading correctly.

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found no new alarms.Visual inspection of external components found the external power to main board cable port damaged.Visual inspection of internal components found crack in bottom right anchor boss of the front driver housing with a pin-nut protruding.Inspection also found a scuff/burn mark to the speaker to lcd ribbon cable and secondary motor out of primary alignment.Freedom driver passed all areas of functional testing for acceptance at incoming inspection with cable held in place with tape until part could be scrapped after investigation.Additional testing included a hypervolemia test to mimic fluid overload per customer report.Fill volume dropped, replicating customer reported experience, however, this is a common occurrence with the freedom driver software where the fill volume readings drop when patient's fluid intake is too high.This is a known issue that is currently being addressed with updated software versions but is not considered a device malfunction.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; root cause of the drop in fill volumes was due to the current freedom driver software version that does not accommodate accurate readings on a fluid overloaded patient.This is not a device a malfunction but a known issue that is currently being addressed with updated software.Failure investigation identified no test failures or damage that could have contributed to the complaint.External and internal damage was cosmetic and did not disrupt the functionality of the driver.No device malfunction was found.Patient condition was hypervolemic and therefore were operating the device outside of normotensive requirements.Patient's condition was stabilized with hospital intervention and switched to a backup companion 2 driver without any additional reported adverse impact.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 14408532
• MDR Text Key: 291731989
• Report Number: 3003761017-2022-00044
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male