MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problems Material Discolored (1170); Physical Property Issue (3008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2018

Event Type  malfunction  

Manufacturer Narrative

The tah-t cannula will not be returned to syncardia for evaluation as the tah-t remains implanted.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the cannula on the tah-t was turning brown-colored.There was no reported patient impact.

Event Description

The customer, a syncardia certified hospital, reported that the cannula on the tah-t was turning brown-colored.There was no reported patient impact.

Manufacturer Narrative

The tah-t cannula was not returned to syncardia for evaluation as the tah-t remains implanted.Review of the photo submitted by the customer confirmed the reported darkened, discolored cannulae.It is likely that the darkening of the cannulae resulted from exposure to environmental factors in the patient's surroundings or from the age of the material.This pattern is consistent with previously-reported instances of darkened cannula.The root cause of the darkened cannulae cannot be conclusively determined, but appears to be consistent with the cannulae discoloration investigated in previously with other patients.The freedom driver system operator manual (f-900012-de) and the freedom driver system guidebook for patients and caregivers (f-900015-de) instruct patients to examine their cannulae regularly and to not use cleaners on the drivelines, cannulae, drivers or driver accessories.Users are to use extreme care when cleaning the freedom driver and drivelines, and to wipe the drivelines gently with a soft, clean cloth lightly dampened only with water.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.

Manufacturer Narrative

The tah-t cannula was not returned to syncardia for evaluation as the tah-t remains implanted.Review of the photo submitted by the customer confirmed the reported darkened, discolored cannulae.It is likely that the darkening of the cannulae resulted from exposure to environmental factors in the patient's surroundings or from the age of the material.This pattern is consistent with previously-reported instances of darkened cannula.The root cause of the darkened cannulae cannot be conclusively determined, but appears to be consistent with the cannulae discoloration investigated in previously with other patients.The freedom driver system operator manual (f-900012-de) and the freedom driver system guidebook for patients and caregivers (f-900015-de) instruct patients to examine their cannulae regularly and to not use cleaners on the drivelines, cannulae, drivers or driver accessories.Users are to use extreme care when cleaning the freedom driver and drivelines, and to wipe the drivelines gently with a soft, clean cloth lightly dampened only with water.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 customer, a syncardia certified hospital, reported that the cannula on the tah-t was turning brown-colored.There was no reported patient impact.

• 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
• MDR Report Key: 7260150
• MDR Text Key: 100146809
• Report Number: 3003761017-2018-00038
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 500101
• Device Lot Number: 087171
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR