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

Catalog Number 500101

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that there is a small leak on the tah-t left cannula.The customer also reported that the 70cc tah-t cannula was repaired.There was no reported adverse patient impact as a result of the cannula leak and subsequent repair.This alleged failure mode poses a low risk to the patient because although there was a cannula leak, the tah-t continued to perform its life-sustaining functions.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear/leak 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 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 patient was implanted with the syncardia 70cc temporary total artificial heart (tah-t) on (b)(6) 2014 and had been supported by the tah-t system for 609 days when the customer reported that there was a small air leak inn the patient's tah-t left cannula.The customer also reported that the cannula was repaired by cutting off the section of the cannula with the air leak and reinserting the cpc connector.There was no reported adverse patient impact as a result of the cannula leak and subsequent repair.The damaged section of the 70cc tah-t cannula was not returned by the customer to syncardia, and therefore it could not be evaluated.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.The patient was successfully transplanted on (b)(6) 2016.Syncardia has initiated a capa (corrective/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 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.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.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5677195
• MDR Text Key: 46473832
• Report Number: 3003761017-2016-00209
• 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,Followup
• Report Date: 05/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 500101
• Device Lot Number: 095781-SYNHALL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR