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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA HAND PUMP
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SYNCARDIA SYSTEMS, LLC SYNCARDIA HAND PUMP Back to Search Results
Catalog Number 397004-001
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 12/08/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to a patient because the damage to the hand pump was observed when it was not in use on a patient.The hand pump will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The syncardia hand pump was not in patient use.The syncardia hand pump is an accessory to the companion 2 driver system.The hand pump is designed to provide manual short-term emergency support of the syncardia tah-t in the event of a driver failure.The customer reported that the hand pump had a crack.
 
Manufacturer Narrative
The hand pump was returned to syncardia for evaluation.Visual inspection of the hand pump's exterior components revealed cracked housings, confirming the customer-reported issue.The hand pump did not pass physical requirements due to the housing misalignment.The hand pump passed functional requirements with regard to cardiac output at both normotensive and hypertensive settings.Internal inspections of the hand pump revealed broken standoffs and dislodged swage nuts and are an indication that the unit was subjected to an impact shock, which is the probable cause of the damage observed.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 the file.(b)(4).
 
Event Description
The syncardia hand pump was not in patient use.The syncardia hand pump is an accessory to the companion 2 driver system.The hand pump is designed to provide manual short-term emergency support of the syncardia tah-t in the event of a driver failure.The customer reported that the hand pump had a crack.
 
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Brand Name
SYNCARDIA HAND PUMP
Type of Device
HAND PUMP
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 Key6186741
MDR Text Key63191693
Report Number3003761017-2016-00400
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
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397004-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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