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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 Problems Crack (1135); Loose or Intermittent Connection (1371)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2017
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.
 
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.The customer, a certified syncardia hospital, reported that the housing is cracked and a loose piece can be heard inside housing.
 
Manufacturer Narrative
The hand pump was returned to syncardia for evaluation.Visual inspection of the hand pump revealed multiple scuffs, cracks and chips along the body and seams, and a broken piece of housing loose inside the unit.The customer-reported damage was confirmed.Although the root cause for the customer reported loose part is not known, based on the evidence provided in this investigation, it is likely that the hand pump experienced an impact shock.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) follow-up report 1.
 
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.The customer, a certified syncardia hospital, reported that the housing is cracked and a loose piece can be heard inside housing.
 
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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 Key6714515
MDR Text Key80276351
Report Number3003761017-2017-00121
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 Health Professional
Type of Report Initial,Followup
Report Date 06/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2017
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 Manufacturer07/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2012
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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