MAUDE Adverse Event Report: ABIOMED INC. OXY-1 CONSOLE; ABIOMED BREETHE OXY-1 SYSTEM

Model Number OXY-1 CONSOLE

Device Problem Pumping Stopped (1503)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

The medical center returned the breethe console system for evaluation and product analysis.The root cause of the blood flow sensor alarm and console failure was found to be a software issue.The failure mode will be monitored and trended.

Event Description

A patient was admitted with a covid+ diagnosis and placed on ecmo support in (b)(6) of 2021.In (b)(6) of 2021 he was placed on his 3rd ecmo support, which was his first breethe ecmo console.After 13 days of support the breethe console alarmed for a blood flow sensor failure.This prompted the medical team to replaced the console when it shut down.The team replaced the console with another and support proceeded.

Manufacturer Narrative

Change health effect clinical code from 1914 to 4582, as there was no injury reported.Remove 4617 from health effect impact code as patient was not injured.Add 765 as component code.

• Brand Name: OXY-1 CONSOLE
• Type of Device: ABIOMED BREETHE OXY-1 SYSTEM
• Manufacturer (Section D): ABIOMED INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): BREETHE INC.; 1500 joh ave suite 190; halethorpe MD 21227
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 13042507
• MDR Text Key: 283693700
• Report Number: 1220648-2021-01205
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 860001797930
• UDI-Public: (01)860001797930(10)20200309(11)201027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200109
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OXY-1 CONSOLE
• Device Catalogue Number: 001-3300-011
• Device Lot Number: 20200309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/17/2021
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White