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

Catalog Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Pulmonary Embolism (1498); Syncope (1610)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited intermittent fault alarms, the freedom driver continued to perform its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer reported that the patient participated in physical therapy early on (b)(6) 2016 and they performed deep tissue manipulation on his hip, after which the patient reported that he didn't feel well but his symptoms were not well defined.The customer also reported that on (b)(6) 2016 freedom driver s/n (b)(4) exhibited intermittent fault alarms (mfr.Report # 3003761017-2016-00322) and the patient felt like the freedom driver wasn't working and switched to his backup freedom driver s/n (b)(4).The customer also reported that at 3:30 am on (b)(6) 2016 freedom driver s/n (b)(4) exhibited a continuous fault alarm (mfr.Report # 3003761017-2016-00328) and the patient was unresponsive.The patient was switched to his backup freedom driver s/n (b)(4) and regained consciousness.The patient was instructed to come to the emergency room at ucla.The customer also reported that during the car ride to ucla, freedom driver s/n (b)(4) exhibited a fault alarm (mfr.Report # 3003761017-2016-00329), however the patient did not switch drivers because the other two freedom drivers they had with them had already exhibited fault alarms.The patient was awake and alert during the car ride and arrived at ucla with freedom driver s/n (b)(4) exhibiting a fault alarm.The customer also reported that after the patient arrived in the emergency room at 5:00 am freedom driver s/n (b)(4) then went into a continuous fault alarm and the patient started to lose consciousness.The patient was switched from freedom driver s/n (b)(4) to a companion 2 driver and he regained consciousness.The customer also reported that all three freedom drivers continued pumping during their alarms.The customer also reported that on (b)(6) 2016 a ct angiogram was performed on the patient and a pulmonary embolism was confirmed.The customer also reported that they believe the fault alarms were caused by patient conditions.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The driver in "as received condition" passed all testing requirements, which included nominal normotensive and hypertensive settings with no anomalies or alarms.In addition, the driver was tested for an additional 48 hours and the driver performed as intended with no issues.The customer-reported intermittent fault alarms were not reproduced.Review of the electronic data revealed that there was no record of a permanent fault alarm while supporting the patient.Only permanent fault alarms are recorded in the electronic data.Intermittent, recoverable and battery alarms are not recorded.The customer experience was not duplicated and the root cause of the customer-reported intermittent fault alarms could not be determined and there was no evidence of a device malfunction.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.(b)(4) follow-up report 1.

Event Description

The customer reported that the patient participated in physical therapy early on (b)(6) 2016 and they performed deep tissue manipulation on his hip, after which the patient reported that he didn't feel well but his symptoms were not well defined.The customer also reported that on (b)(6) 2016 freedom driver s/n (b)(4) exhibited intermittent fault alarms (mfr.Report # 3003761017-2016-00322) and the patient felt like the freedom driver wasn't working and switched to his backup freedom driver s/n (b)(4).The customer also reported that at 3:30 am on (b)(6) 2016 freedom driver s/n (b)(4) exhibited a continuous fault alarm (mfr.Report # 3003761017-2016-00328) and the patient was unresponsive.The patient was switched to his backup freedom driver s/n (b)(4) and regained consciousness.The patient was instructed to come to the emergency room at (b)(6).The customer also reported that during the car ride to (b)(6), freedom driver s/n (b)(4) exhibited a fault alarm (mfr.Report # 3003761017-2016-00329), however the patient did not switch drivers because the other two freedom drivers they had with them had already exhibited fault alarms.The patient was awake and alert during the car ride and arrived at (b)(6) with freedom driver s/n (b)(4) exhibiting a fault alarm.The customer also reported that after the patient arrived in the emergency room at 5:00 am freedom driver s/n (b)(4) then went into a continuous fault alarm and the patient started to lose consciousness.The patient was switched from freedom driver s/n (b)(4) to a companion 2 driver and he regained consciousness.The customer also reported that all three freedom drivers continued pumping during their alarms.The customer also reported that on (b)(6) 2016 a ct angiogram was performed on the patient and a pulmonary embolism was confirmed.The customer also reported that they believe the fault alarms were caused by patient conditions.

• 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 Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6011609
• MDR Text Key: 57360374
• Report Number: 3003761017-2016-00322
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• 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: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2011
• 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: 31 YR