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 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

The cpc connector will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(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 during a clinic visit after a driver exchange, it was discovered that the cpc connector on the tah-t cannula had a displaced spring.There was no reported adverse patient impact.The customer also reported that the physician replaced the connector.

Manufacturer Narrative

Visual inspection confirmed the customer-reported issue of a displaced spring, as the spring inside the left (female) cpc connector was displaced inside the housing beneath the metal release tab.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 of this complaint and is closing this file.Ce (b)(4) follow-up report 1.

• 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
• MDR Report Key: 9996766
• MDR Text Key: 200777670
• Report Number: 3003761017-2020-00123
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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: 119223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR