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

Catalog Number 500101

Device Problems Use of Device Problem (1670); Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The tah-t cpc connector is a component that provides the interface between the tah-t cannula and the drivelines and is secured in place by the use of wire ties.The customer reported that the patient's left cpc connector disconnected from the tah-t cannula.The customer also reported that the hospital staff reconnected the cpc connector to the cannula and replaced the wire ties.There was no reported adverse patient impact.The customer was retrained by syncardia personnel to have the vad coordinator check the cpc cannula/driveline connections prior to leaving the operating room to ensure that the wire ties are securely in place.The icu nursing team was also retrained to document that the wire ties are in place when the patient arrives post implant.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 TAH-T CANNULA
• 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: 5918229
• MDR Text Key: 53671884
• Report Number: 3003761017-2016-00312
• 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: 08/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 47 YR