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

Catalog Number 397002-001

Device Problems No Display/Image (1183); Mechanical Problem (1384); Poor Quality Image (1408); Pumping Stopped (1503); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver display turned gray while the patient was in the operating room prior to heart transplant surgery.The customer also reported that the display turned gray when the nurse attempted to change the heart rate from 125 to 129 bpm (beats per minute).When the driver's display returned to normal, the beat rate was at 0 and the driver stopped pumping for a few seconds.The customer also reported that the hospital staff member was able to increase the beat rate and return the driver to fully functional by pushing the (+) sign on the driver.The customer also reported that the patient was successfully transplanted with a heart on the same day.There was no reported adverse patient impact.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

Corrected data: there was no reported adverse patient impact.(b)(4).

Event Description

The customer reported that the companion 2 driver display turned gray while the patient was in the operating room prior to heart transplant surgery.The customer also reported that the display turned gray when the nurse attempted to change the heart rate from 125 to 129 bpm (beats per minute).When the driver's display returned to normal, the beat rate was at 0 and the driver stopped pumping for a few seconds.The customer also reported that the hospital staff member was able to increase the beat rate and return the driver to fully functional by pushing the (+) sign on the driver.The customer also reported that the patient was successfully transplanted with a heart on the same day.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the external components revealed no anomalies.During visual inspection of the internal components, no damage was observed on the corresponding cables that could potentially affect the driver's display.The low-voltage differential signaling (lvds) and liquid crystal display (lcd) inverter cables, which are responsible for the driver display, were manipulated during investigation testing, and the reported gray screen was not reproduced.Both were examined and were found to be free of damage.The electronic patient data file was reviewed, and various alarms standard to normal driver operation were observed.However, none of the alarms were indicative of a device malfunction or were relevant to the reported issue.If there was an unexpected shutdown or loss of communication, a "computer malfunction" alarm would be recorded in the patient data file, and an error code would be recorded in the eeprom data.No "computer malfunction" alarm or error code was recorded.The electronic patient data file showed a controlled descent of the beat rate over time as per standard protocols while preparing for bypass support.It is likely that during this time the beat rate was unintentionally lowered to zero bpm and then returned to its previous setting.However, this could not be confirmed.During investigation testing, it was observed that if the driver's beat rate was lowered to zero bpm and returned to its previous settings in less than a minute, the patient data file would not record the change.Decrease in beat rate was only achieved through intentional manipulation of the beat rate in operating room (or) mode.The investigation concluded that the companion 2 driver performed as intended, and there was no evidence of a device malfunction.The companion 2 driver was serviced and passed all final performance testing.There was no reported adverse impact to the patient as a result of the reported issue.Since the beat rate was able to be returned to the desired settings by the customer, the patient was not switched to a backup driver.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 COMPANION 2 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: 5347945
• MDR Text Key: 35641134
• Report Number: 3003761017-2016-00001
• 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
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• 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: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2012
• 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 Outcome(s): Disability
• Patient Age: 70 YR