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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 Pressure Problem (3012); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited irregular left pressure waveforms while supporting a patient.The customer also reported that the patient's systolic blood pressure was at 120 and the companion 2 driver's output pressure was set at 200 millimeters of mercury (mmhg).The customer also reported that the patient's lab values reflected hemolysis on the day of the reported event.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 irregular left pressure waveforms, 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 irregular left pressure waveforms while supporting a patient.The customer also reported that the patient's systolic blood pressure was at 120 and the companion 2 driver's output pressure was set at 200 millimeters of mercury (mmhg).The customer also reported that the patient's lab values reflected hemolysis on the day of the reported event.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.Visual inspection of the driver's external components revealed no anomalies.The patient data file was copied and reviewed, confirming the left pressure incorrect alarms as reported by the customer.During failure 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.Syncardia has initiated a corrective action (capa) to address the issue with electronic pressure regulators in relation to pressure incorrect alarms the investigation is in process.Potential corrective actions will be evaluated when the root cause investigation has been completed.It is unlikely that the higher left pressure would be the cause of the patient's hemolysis reported by the customer.Once the driveline pressure increases to the point of achieving the full eject flag, the diaphragm is in the full "up" position.When this occurs, any further increase in pressure would be isolated to the diaphragm of the patient's tah-t and is not transferred to the patient's blood.Despite the customer-reported left pressure incorrect alarms, risk to the patient was low because the driver continued to perform its life-sustaining functions.The driver was serviced and passed all functional and performance testing prior to being released to finished goods.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 (Section G)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5171719
MDR Text Key29820048
Report Number3003761017-2015-00365
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 10/19/2015
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? Yes
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 Manufacturer10/23/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2014
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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