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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
Catalog Number 500101
Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient had been supported by the tah-t system for 341 days at the time of the reported issue.The customer reported that the velour coverings on the 70cc tah-t cannulae were "moving/rotating on the cannulae".The customer also reported that the 70cc tah-t cannulae were successfully repaired by the hospital staff by applying silicone tape at the distal edge of the velour/cannula intersection to ensure no rotation of the velour on cannulae was able to occur.There was no reported adverse patient impact as a result of the velour rotation on the cannulae and subsequent repair.This alleged failure mode poses a low risk to the patient because although there was a rotation of the velour on the tah-t cannulae, the tah-t system continued to perform its life-sustaining functions.The tah-t is still implanted in the patient.Syncardia has requested that the tah-t and cannulae be returned to syncardia for evaluation after the patient has been transplanted.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The tah-t was still implanted in the patient at the time of the complaint.Syncardia requested that the tah-t and cannulae be returned to syncardia for evaluation after the patient was transplanted.An explant evaluation was completed on tah-t l/n 090260 when returned to syncardia after the patient was transplanted, however, the explanted tah-t did not contain the cannulae or cannula velour.Therefore, an evaluation of the repaired cannulae section could not be performed.A device history record review determined 70cc tah-t, lot# 090260 met all specified requirements prior to shipment.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia completed its evaluation of this complaint and is closing the file.(b)(4).
 
Event Description
The patient had been supported by the tah-t system for 341 days at the time of the reported issue.The customer reported that the velour coverings on the 70cc tah-t cannulae were "moving/rotating on the cannulae".The customer also reported that the 70cc tah-t cannulae were successfully repaired by the hospital staff by applying silicone tape at the distal edge of the velour/cannula intersection to ensure no rotation of the velour on cannulae was able to occur.There was no reported adverse patient impact as a result of the velour rotation on the cannulae and subsequent repair.
 
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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 Key5836846
MDR Text Key52172389
Report Number3003761017-2016-00266
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 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2016
Device Catalogue Number500101
Device Lot Number090260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2013
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 Age27 YR
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