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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems Electrical /Electronic Property Problem (1198); Pressure Problem (3012)
Patient Problem No Patient Involvement (2645)
Event Date 10/09/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver was exhibiting irregular pressure waveforms.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.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
(b)(4).Follow-up report 1.
 
Event Description
The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver was exhibiting irregular pressure waveforms.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver was returned to syncardia for evaluation.The patient file was copied and reviewed, revealing no anomalies.Visual inspection of the driver's external components revealed no anomalies.During investigation testing, the reported irregular pressure waveform was confirmed.The root cause of the irregular pressure waveform was a malfunction of the right electronic pressure regulator.The right electronic pressure regulator was taken out of service and replaced.The issue with the electronic pressure regulators in relation to irregular pressure waveforms regulator is being investigated in a capa (corrective or preventive action).The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with compressor cycling because of a malfunction of the manual pressure regulator.A small timing difference between the left and right pressure waveforms was also observed during failure investigation testing, which was caused by a malfunction of the right pilot valve.The right pilot valve was taken out of service and replaced.These failure modes posed a low risk to a patient because the driver was not supporting a patient at the time of the reported issue, and they would not have prevented the driver from performing its life-sustaining functions.The companion 2 driver was serviced and passed all functional and performance testing 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.
 
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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 Key5154682
MDR Text Key28741341
Report Number3003761017-2015-00356
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
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 10/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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