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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T CANNULA; BIVENTRICULAR REPLACEMENT DEVICE
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SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T CANNULA; BIVENTRICULAR REPLACEMENT DEVICE Back to Search Results
Catalog Number 500101
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Physical Property Issue (3008); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient had a small tear on the 70cc tah-t cannula near the tie band on the patient side of the cpc connectors.The customer also reported that there was an associated air leak with the tear and intermittent fault alarms and dropping fill volumes on the freedom driver during assessment.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.This alleged failure mode poses a low risk to the patient because although there was a small tear on the tah-t cannula, the tah-t system continued to perform its life-sustaining functions.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.The removed tah-t cannula piece will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The removed tah-t cannula piece was returned to syncardia for evaluation.The customer-reported cannula tear was confirmed through physical examination of the returned section of left cannula.Similar to other malfunctions observed in the field and previously documented, this tear occurred near the cannula/cpc junction.The tear penetrated all layers of the cannula, which could have allowed air to leak, leading to the intermittent alarms noted in the customer-reported issue.There are multiple contributing causes of cannula tears.As identified in previous cannula tear investigations, patients supported by portable drivers are more likely to place increased stress on the cannulae.These stresses are concentrated where the effective stiffness of the cannula changes, specifically at the velour/cannula junction and the driveline/cannula junction.The increased stresses at these junctions can lead to a cannula tear.This is caused by the different material behaviors of the pvc cannula material, the stainless steel reinforcing wire, the cpc connector and the cannula velour when placed under flexural, rotational or tensile stresses.Wear occurs at the surface or between pvc layers, eventually leading to tear initiation.Syncardia has an open capa (corrective and preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).
 
Event Description
The customer reported that the patient had a small tear on the 70cc tah-t cannula near the tie band on the patient side of the cpc connectors.The customer also reported that there was an associated air leak with the tear and intermittent fault alarms and dropping fill volumes on the freedom driver during assessment.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.
 
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Brand Name
SYNCARDIA 70CC TAH-T CANNULA
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 Key5860424
MDR Text Key52610740
Report Number3003761017-2016-00288
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
Remedial Action Repair
Type of Report Initial,Followup
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2017
Device Catalogue Number500101
Device Lot Number093739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
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 Age55 YR
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