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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC SYNCARDIA COMPANION CADDY
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SYNCARDIA SYSTEMS, INC SYNCARDIA COMPANION CADDY Back to Search Results
Catalog Number 397001-001
Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The companion driver caddy was not in use by a patient.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 reported that the locking mechanism on the companion caddy does not work anymore.The customer also reported that the companion driver caddy has a flat tire.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion driver caddy was not in use by a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion caddy will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The companion driver caddy was not in use by a patient.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 reported that the locking mechanism on the companion caddy does not work anymore.The customer also reported that the companion driver caddy has a flat tire.The companion caddy was returned to syncardia for evaluation.Inspection of the companion caddy's exterior revealed that the tire on the left wheel was not fully inflated and exhibited a slow leak, and the release plunger assembly was difficult to move, thus confirming the customer-reported issues.The root cause of the tire on the left wheel not being fully inflated is most likely the result of normal wear.The malfunction of the release plunger assembly was previously investigated, which identified the root cause to be the result of friction between the interacting metal components of the release plunger assembly.These failure modes pose a low risk to a patient because the companion caddy was not in patient use at the time of the customer-reported issues; therefore, there was no patient impact.The companion 2 driver operates independently from the companion caddy and would have continued to provide its life-sustaining functions.The companion 2 driver could also be docked into another caddy or hospital cart and continue to provide its life-sustaining functions.After replacement of the wheels and release plunger assembly, the companion caddy met the performance testing.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 CADDY
Type of Device
COMPANION CADDY
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 Key5019789
MDR Text Key24689714
Report Number3003761017-2015-00261
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,health pr
Reporter Occupation Other Health Care Professional
Type of Report Followup
Report Date 08/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer08/18/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/20/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2012
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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