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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 Device Displays Incorrect Message (2591); Pressure Problem (3012)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited a left high pressure alarm while supporting a patient.The customer also reported that the alarm messages could not be controlled despite the hospital staff making adjustments to the driver settings.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited left high pressure alarms, it did not prevent the driver from performing its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4) follow-up report 1.
 
Event Description
The customer reported that the companion 2 driver exhibited a left high pressure alarm while supporting a patient.The customer also reported that the alarm messages could not be controlled despite the hospital staff making adjustments to the driver settings.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no anomalies.The patient file was copied and reviewed.Multiple left pressure incorrect alarms were observed.During these alarms, the left pressure was consistently higher than the set point, which confirmed the customer-reported issue.During investigation testing, the customer-reported left pressure incorrect alarm was duplicated.The root cause was a malfunction of the left electronic pressure regulator.The left electronic pressure regulator was taken out of service and replaced.The issues with electronic pressure regulators in relation to pressure incorrect alarms are 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.Despite the customer-reported left pressure incorrect alarms, risk to the patient was low because the driver continued to perform its life-sustaining functions and the cardiac output remained within the acceptable 5 to 8 l/min (liters per minute).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 Key5171724
MDR Text Key29345470
Report Number3003761017-2015-00359
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2015
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 Manufactured02/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age50 YR
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