MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397002-001

Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components are reported under three separate medical device reports: (1) companion 2 driver s/n (b)(4) (mfr report # 3003761017-2016-001230; companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00124), and companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00125).The customer reported that the companion 2 driver was tested prior to the implant surgery and passed the system check.The customer also reported that the companion 2 driver was supporting the patient in the intensive care unit (icu) and that a nurse is always present.The customer also reported that on sunday morning (b)(6) 2016, the companion 2 driver stopped suddenly without any audible alarms in advance.The syncardia clinical support specialist also reported that the doctor came into the hospital room when the driver stop occurred, although it is unclear if the nurses called the doctor into the hospital room.The customer also reported that the doctor in charge quickly inserted replacement external batteries and the driver started pumping.The customer also reported that the doctor stated that "the driver may have stopped a few seconds - around ten seconds only." the customer also reported that the driver's alarm history showed several "low external battery," "very low external battery," "emergency battery" and "computer malfunction" alarms.The customer also reported that the nurses confirmed that they did not hear any alarms, only an alarm when the driver stopped.The syncardia clinical support specialist also reported that another doctor was present in the hospital room and confirmed that the driver stopped and the driver exhibited an alarm afterwards.The doctor immediately exchanged the driver's onboard batteries and the driver began working again.The customer also reported that a disconnected power cord could not be confirmed as a reason for the depletion of the external batteries and internal emergency battery because the driver was plugged in to external wall power all the time.The customer also reported that on sunday evening, (b)(6) 2016, the patient was switched to the backup companion 2 driver.The customer also reported that the doctor said there did not appear to be an adverse impact on the patient as a result of the companion 2 driver reported stop, and the patient is still intubated because of pneumonia.The companion 2 driver and the two external batteries that were installed in the driver at the time of the reported driver stop will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no anomalies.The driver was inspected and tested in accordance with approved procedures, and the driver passed all requirements, including confirmation that the driver alarms activated at the appropriate times and at the required volume.Audible alarm testing confirmed that the speakers were functioning properly, and that all alarms, including the internal audible alarm (main buzzer), annunciated when required.Based on the failure investigation test results and review of the electronic patient file at the time of the customer-reported issue, the driver, while powered only by the external batteries and the emergency battery, functioned as intended, and there was no evidence of a device malfunction.The companion 2 driver was serviced and returned to finished goods.Per the syncardia companion 2 driver system operator manual, chapter 6 companion 2 driver, section.6.5 power, "the driver is designed always to be connected to two power sources - the internal emergency battery and either of the two external batteries and/or and external ac power source.If all power sources are removed or depleted, an audible buzzer will sound.If the driver is operating on one power source, the driver will be in a very high alarm state." 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).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components are reported under three separate medical device reports: (1) companion 2 driver s/n (b)(4) (mfr report # 3003761017-2016-001230) companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00124), and companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00125).The customer reported that the companion 2 driver was tested prior to the implant surgery and passed the system check.The customer also reported that the companion 2 driver was supporting the patient in the intensive care unit (icu) and that a nurse is always present.The customer also reported that on sunday morning march 29, 2016, the companion 2 driver stopped suddenly without any audible alarms in advance.The syncardia clinical support specialist also reported that the doctor came into the hospital room when the driver stop occurred, although it is unclear if the nurses called the doctor into the hospital room.The customer also reported that the doctor in charge quickly inserted replacement external batteries and the driver started pumping.The customer also reported that the doctor stated that "the driver may have stopped a few seconds - around ten seconds only." the customer also reported that the driver's alarm history showed several "low external battery," "very low external battery," "emergency battery" and "computer malfunction" alarms.The customer also reported that the nurses confirmed that they did not hear any alarms, only an alarm when the driver stopped.The syncardia clinical support specialist also reported that another doctor was present in the hospital room and confirmed that the driver stopped and the driver exhibited an alarm afterwards.The doctor immediately exchanged the driver's onboard batteries and the driver began working again.The customer also reported that a disconnected power cord could not be confirmed as a reason for the depletion of the external batteries and internal emergency battery because the driver was plugged in to external wall power all the time.The customer also reported that on sunday evening, (b)(6) 2016, the patient was switched to the backup companion 2 driver.The customer also reported that the doctor said there did not appear to be an adverse impact on the patient as a result of the companion 2 driver reported stop, and the patient is still intubated because of pneumonia.

• Brand Name: SYNCARDIA COMPANION 2 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: 5579651
• MDR Text Key: 43548773
• Report Number: 3003761017-2016-00123
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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: 59 YR