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

Catalog Number 595000-001

Device Problems Break (1069); Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)

Patient Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient was advised to go to (b)(6) to switch to a companion 2 driver since he had previously had two freedom driver fault alarms earlier in the day.The customer also reported that the hospital staff noticed the spring on the blue cpc connector (circular plastic connector) that is connected to the freedom driver was dislodged.The dislodged spring is located on the right side driveline female cpc connector of the driver.The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer also reported that the patient was subsequently switched to a companion 2 driver, where the driver readings displayed a beat rate (br) of 130, fill volumes (fv) 38 to 42, and cardiac output (co) of 4.8 to 5.2.The patient's blood pressure was at 120/91.The customer also reported that the patient was taking extra diuretic at home since his weight had increased (b)(6) pounds.The customer also reported that the patient was subsequently switched to a backup freedom driver.The driver readings displayed a br of 130, fv 50, and co of 6.6.There was no reported patient impact.This alleged failure mode poses a low risk to the patient because although the spring on the cpc connector was dislodged, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4) follow-up report 1.

Event Description

The customer reported that the patient was advised to go to (b)(6) to switch to a companion 2 driver since he had previously had two freedom driver fault alarms earlier in the day.The customer also reported that the hospital staff noticed the spring on the blue cpc connector (circular plastic connector) that is connected to the freedom driver was dislodged.The dislodged spring is located on the right side driveline female cpc connector of the driver.The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer also reported that the patient was subsequently switched to a companion 2 driver, where the driver readings displayed a beat rate (br) of 130, fill volumes (fv) 38 to 42, and cardiac output (co) of 4.8 to 5.2.The patient's blood pressure was at 120/91.The customer also reported that the patient was taking extra diuretic at home since his weight had increased 5 pounds.The customer also reported that the patient was subsequently switched to a backup freedom driver.The driver readings displayed a br of 130, fv 50, and co of 6.6.There was no reported patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed a dislodged spring on the female cpc connector.The customer-reported issue was confirmed.It is unknown how the spring was dislodged from the cpc connector.This issue was previously investigated at syncardia.Clinicians and patients are trained to thread a wire tie through the thumb release tab of cpc connectors to prevent inadvertent disconnection of the cannulae to the drivelines.It is possible that when the wire tie was threaded through the connector, it dislodged the spring.Visual inspection of the internal components of the driver revealed no abnormalities.The driver's alarm history was retrieved from the electronic data and no new alarms were recorded.No alarms were reported by the customer.Despite the dislodged cpc connector spring, the driver in "as received" condition passed all required functional testing requirements with no anomalies or alarms.The customer-reported issue posed a low risk to the patient because it did not prevent the driver from performing its life sustaining-functions.The driver was serviced, which included replacement of both cpc connectors, before being placed into finished goods.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.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5492622
• MDR Text Key: 40414103
• Report Number: 3003761017-2016-00078
• Device Sequence Number: 1
• Product Code: LOZ
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• 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: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2012
• 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 Age: 54 YR