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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems Device Stops Intermittently (1599); Device Operational Issue (2914)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 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.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.The customer reported that there was no adverse patient impact and the patient continued to be supported by this companion 2 driver until his transplant.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.Review of the patient file revealed multiple external air connected notifications.This is an indication that the necessary conditions required for the driver to operate exclusively on external air were not consistently met, thereby causing the driver to disable the external air connected icon and activate the primary compressor.This confirmed the customer-reported issue.Investigation testing was performed to reproduce the "compressor cycling" as observed by the customer.During the observation run, intermittent compressor cycling did occur, thus reproducing the customer experience.A malfunction of the manual pressure regulator to maintain the required pressure set point value was identified as the root cause.The issue of compressor cycling because of a malfunction of the manual pressure regulator is being investigated in a capa (corrective and 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.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.The customer reported that there was no adverse patient impact and the patient continued to be supported by this companion 2 driver until his transplant.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
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 Key6360239
MDR Text Key68759318
Report Number3003761017-2017-00042
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier0858000003107
UDI-Public(01)0858000003107
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
Type of Report Initial,Followup
Report Date 02/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
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 Manufacturer03/01/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2014
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 Age64 YR
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