MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION HOSPITAL CART; CIRCULATORY ASSIST DEVICE

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The hospital cart can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer reported that the electrical power cord became detached from the companion hospital cart "about every other day." the customer also reported that there was no patient impact and the patient was still being supported by the companion 2 driver and companion hospital cart.This alleged failure mode poses a low risk to the patients because it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of external batteries and an internal, emergency battery.

Manufacturer Narrative

An investigation will be conducted by syncardia and the results will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq., vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3937458
• MDR Text Key: 4534096
• Report Number: 3003761017-2014-00054
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/14/2014

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: N/A
• Device Catalogue Number: 397003-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR