MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problem Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6) is a study subject in (b)(6) with 525 days of support as of (b)(6) 2018.The area of the tah-t cannula with the tear was repaired by the hospital by means of applying rescue tape over the tear and was therefore not returned to syncardia for investigation.Syncardia conducted a review of the tah-t device history record (dhr) and sterilization work order and confirmed that all manufacturing was performed to specifications, and the 70cc tah-t met all specified requirements prior to shipment.Syncardia has a corrective and preventive action (capa) to address the cannula tear issue.The syncardia freedom driver system guidebook for patients and caregivers - us, instructs the patients and caregivers 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.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient observed a small tear in the 70cc tah-t cannula.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.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (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 Key: 7341420
• MDR Text Key: 102593783
• Report Number: 3003761017-2018-00076
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• 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
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 500101
• Device Lot Number: 105701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR