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

Model Number 500101-001

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the customer provided photograph confirmed the spring was missing from the cpc connector.Clinicians and patients are trained to thread a wire tie through the thumb release tab of the cpc connectors to prevent inadvertent disconnection of the cannulae from the drivelines.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.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) follow-up report 1.

Event Description

The customer, a syncardia certified hospital, reported that the spring in the cpc connector of the cannula was displaced.The customer also reported that staff manipulated the cpc connector and the spring was subsequently dislodged and lost.The customer also reported that the cpc connector was replaced at the hospital and there was no clinical impact on the patient.

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 8009794
• MDR Text Key: 126083399
• Report Number: 3003761017-2018-00485
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 114196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR