MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problems Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

The companion hospital cart will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

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 customer, a syncardia certified hospital, reported that while supporting a patient the companion hospital cart's electrical outlet was faulty as there was a false contact when the cable was moved.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection was performed and no damage to external or internal components, including electrical connections and contacts, was observed.The hospital cart passed all incoming functional testing.Additionally, the power cable was found to lock securely in place and no issues were found with the connectivity of the external power cable.During investigation testing, a fluke multimeter was used to measure output at pins 41 and 43 and also at pins 42 and 44 located on the power control printed circuit board.Initially when the power cord was connected, both sets of pins read 18.03 volts, which is within specification.The external power cable was manipulated and remained locked in place with no change in voltage.However, after approximately 5 minutes, the cooling fan turned on and a power drop was observed.This drop in power could give the appearance that there was an issue with the electrical outlet as reported by the customer.The root cause of the hospital cart not providing sufficient power was determined to be a malfunction of the temperature proportional speed control feature of the u2 chip on the power control printed circuit board of the hospital cart.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10125783
• MDR Text Key: 196421540
• Report Number: 3003761017-2020-00140
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2012
• 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: 42 YR
• Patient Sex: Female