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

Model Number 500101-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the photograph provided by the hospital confirmed the reported displaced spring in the cpc connector.Clinicians and patients are trained to thread a wire tie beneath the thumb release tab of the cpc connectors to prevent accidental disconnection of the cannulae from the drivelines.However, the labeling does not provide specific instruction on how to perform the insertion and removal of wire ties, and it does not clearly explain the original purpose of the wire ties.There are no warnings associated with the dislocation of the spring inside the cpc connectors in tah-t and driver labeling.Although a definitive root cause for the displaced spring could not be determined, it is possible that a cpc connector spring can be displaced when the wire tie is threaded through, or removed from, the connector during or after a driver switch or during driver training.Syncardia has an open corrective and preventive action (capa) to address this issue with cpc connectors.Syncardia has completed its evaluation and is closing this file.(b)(4).

Event Description

The cpc (colder products company) connector is a component that provides the interface between the driver drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the cpc connector on the tah-t cannula had a displaced spring.The customer also reported that the vad coordinator was able to reach behind the metal tab and move the spring back into place.There was no reported adverse patient impact.

• 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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, az ; 5451234120
• MDR Report Key: 10426475
• MDR Text Key: 203854673
• Report Number: 3003761017-2020-00164
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• 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
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 110944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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: 66 YR