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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION CADDY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION CADDY Back to Search Results
Catalog Number 397001-001
Device Problems Mechanical Problem (1384); Power Problem (3010)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to a patient because the caddy issues would not prevent the companion 2 driver from performing its life-sustaining functions.The companion driver caddy will be returned to syncardia for investigation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia authorized distributor, reported that the companion 2 driver locking mechanism does not work and it has a flat tire.The customer also reported the caddy was replaced with a backup caddy.
 
Manufacturer Narrative
The companion driver caddy was returned to syncardia for investigation.The reported issue of "flat wheel" was confirmed.The root cause was determined to be a ruptured inner tube.Visual inspection confirmed the customer-reported issue of the companion 2 driver locking mechanism not working properly as the release plunger assembly was observed to be stuck in the open position.This is a known issue that has been previously documented and investigated; it determined that a lack of internal lubrication was the root cause for the release plunger assembly to be stuck in the open or closed positions.The device history records review of companion driver caddy s/n 60065 indicated that the release plunger assembly was installed prior to the most current drawing, and was therefore replaced in accordance with the caddy service shop order when it was returned from the field.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.(b)(4).
 
Event Description
The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia authorized distributor, reported that the companion 2 driver locking mechanism does not work and it has a flat tire.The customer also reported the caddy was replaced with a backup caddy.
 
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Brand Name
SYNCARDIA COMPANION CADDY
Type of Device
COMPANION CADDY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6836356
MDR Text Key85613537
Report Number3003761017-2017-00154
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397001-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2013
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 Age63 YR
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