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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA; BIVENTRICULAR REPLACEMENT DEVICE
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SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA; BIVENTRICULAR REPLACEMENT DEVICE Back to Search Results
Catalog Number 500101
Device Problems Break (1069); Material Rupture (1546); Device Displays Incorrect Message (2591)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient exhibited a red alarm when he was in his vehicle.The customer also reported there was a low cardiac output (co) display at the time of the alarm.The customer also reported that the patient felt "very badly." the customer also reported that an ambulance was called.The customer also reported that when the patient arrived at the hospital, the staff found a tear on the 70cc tah-t left cannula that is connected to a freedom driver that was supporting a patient.The customer also reported that the 70cc tah-t left cannula was successfully repaired.The customer also reported that the patient was subsequently switched to a companion driver, where co levels returned back to normal and the patient felt fine after the driver switch and 70cc tah-t cannula repair.Syncardia has initiated a 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.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
(b)(4).
 
Event Description
The customer reported that the patient exhibited a red alarm when he was in his vehicle.The customer also reported there was a low cardiac output (co) display at the time of the alarm.The customer also reported that the patient felt "very badly." the customer also reported that an ambulance was called.The customer also reported that when the patient arrived at the hospital, the staff found a tear on the 70cc tah-t left cannula that is connected to a freedom driver that was supporting the patient.The customer also reported that the 70cc tah-t left cannula was successfully repaired.The customer also reported that the patient was subsequently switched to a companion driver, where co levels returned back to normal and the patient felt fine after the driver switch and 70cc tah-t cannula repair.As of (b)(6) 2016, the patient currently remains at home on tah-t support with total support duration of 267 days.The removed tah-t cannula piece was returned to syncardia for evaluation.The customer-reported cannula tear was confirmed.This tear occurred at the distal end of the cannula (the driver end) near the cpc connector.The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.Syncardia has initiated a 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.Per the syncardia freedom driver system guidebook for patients and caregivers - ous, end users are instructed to inspect the drivelines and cannulae daily.If a hole is observed in the drivelines or cannulae, household tape must be applied to temporarily repair the hole and the hospital contact person must be contacted to arrange for a hospital-based evaluation.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.
 
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Brand Name
SYNCARDIA 70CC TAH-T CANNULA
Type of Device
BIVENTRICULAR REPLACEMENT DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer (Section G)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5141649
MDR Text Key28377657
Report Number3003761017-2015-00323
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Remedial Action Repair
Type of Report Initial,Followup
Report Date 10/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number500101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2015
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 Age42 YR
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