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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 False Alarm (1013); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited incorrect left pressure alarms while supporting a patient.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 incorrect left pressure alarms, the companion 2 driver continued to perform its life-sustaining functions.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).
 
Event Description
The customer reported that the companion 2 driver exhibited incorrect left pressure alarms while supporting a patient.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 internal components revealed a dented capacitor body on the power management board (pmb).This capacitor body damage has been previously observed and is suspected to be caused by rough handling during shipping of the driver.The pmb continued to provide the expected performance with the dented capacitor body.Therefore, the damage is only cosmetic, and is unrelated to the ce for which this investigation was conducted.The pmb was replaced during service as a precautionary measure.The patient electronic file was copied and reviewed, which confirmed the left pressure incorrect alarms as reported by the customer.During failure investigation testing, a malfunction of the left electronic pressure regulator was identified as the root cause of the left pressure incorrect alarms reported by the customer.Issues with electronic pressure regulators in relation to pressure incorrect alarms are being addressed in a corrective and preventive action (capa) which is still under investigation.The left electronic regulator was replaced and the driver passed all performance and functional testing before being released to finished goods.This failure mode poses a low risk to the patient because the driver continued to perform its life-sustaining functions.The patient was switched to a backup driver without adverse impact.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 (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 Key5243013
MDR Text Key32142875
Report Number3003761017-2015-00393
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 11/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2015
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 Manufacturer11/20/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2015
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 Age66 YR
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