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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE
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SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE Back to Search Results
Model Number 500101-001
Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2017
Event Type  malfunction  
Manufacturer Narrative
The cpc connector 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 customer, a syncardia authorized distributor, reported that the spring in the cpc connector of the cannula was displaced.The customer also reported that the cpc connector was replaced at the hospital and there was no clinical impact on the patient.
 
Manufacturer Narrative
The cpc connector was returned to syncardia for evaluation.The results of the visual inspection of the cpc connector aligned with the customer-reported description.The left female cpc connector spring was displaced inside the housing.It cannot be conclusively determined when the spring became displaced within the housing, and how the spring became dislodged from the cpc connector.However, the most likely root cause based on the available evidence is that the spring was displaced/became misaligned after a previous driver switch out.Syncardia has an open corrective and preventive action (capa) to address this issue with cpc connectors.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Event Description
The customer, a syncardia authorized distributor, reported that the spring in the cpc connector of the cannula was displaced.The customer also reported that the cpc connector was replaced at the hospital and there was no clinical impact on the patient.
 
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Brand Name
SYNCARDIA 70CC TAH-T
Type of Device
BIVENTRICULAR REPLACEMENT DEVICE
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 Key6608162
MDR Text Key76713367
Report Number3003761017-2017-00090
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003008
UDI-Public(01)00858000003008(10)107133(11)16083
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 Repair
Type of Report Initial,Followup
Report Date 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Model Number500101-001
Device Catalogue Number500101
Device Lot Number107133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age41 YR
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