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

Catalog Number 500101

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

The damaged sections of the 70cc tah-t cannula were 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.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.Syncardia has completed its evaluation of this complaint and is closing this file.

Event Description

The customer, a (b)(6) hospital, reported on (b)(6) 2017 the following patient events: pt (b)(6) was admitted (b)(6) 2016 and discharged (b)(6) 2016 for the left cannula not secured on the cpc connector.The customer put a new ziptie on the left cannula to secure the connection to the cpc connector.There was no reported adverse patient impact pt (b)(6) was admitted (b)(6) 2016 and discharged (b)(6) 2016 for a cannula tear on both the left and right sides requiring repairs.The cannulae were repaired by cutting off the sections 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 leaks and subsequent repairs.Pt (b)(6) was admitted (b)(6) 2016 and discharged (b)(6) 2016 for a cannula tear on both the left and right sides requiring repairs.The cannulae were repaired by cutting off the sections 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 leaks and subsequent repairs.Pt (b)(6) was admitted (b)(6) 2016 and discharged (b)(6) 2016 for a cannula tear on both the left and right sides requiring repairs.The cannulae were repaired by cutting off the sections 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 leaks and subsequent repairs.((b)(4)).

• 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: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6289401
• MDR Text Key: 66156033
• Report Number: 3003761017-2017-00024
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008(10)105679(11)16042
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 500101
• Device Lot Number: 105679-70CC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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: 57 YR