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

Model Number OXY-1 CONSOLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Hypothermia (1915)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

The console was not returned for evaluation to date.Upon receipt of device, or any new information, a supplemental mdr will be filed.

Event Description

The complainant reported a (b)(6) male patient with presenting with covid.The breethe ecmo system was selected for support and initiated without any reported issues.Approximately 2 days into support, the patient's temperature fell to 32 degrees celsius and symptoms of bradycardia and hypo-coagulability were exhibited.As treatment, a bair hugger and warming blankets were placed on the patient for 24 hours until the patient's temperature was brought back up.

Manufacturer Narrative

The device was not received by the customer, therefore, a physical evaluation of the device was not be conducted.Analysis of the clinical event concludes the device functioned as intended for the duration of support and the temperature drop was due to patient condition.

Manufacturer Narrative

D(4): revised lot number, added serial number, and revised udi.H(4): revise manufacturing date.H(7): change "recall" from "yes" to "no" and remove recall number- entered in error.

• Brand Name: OXY-1 CONSOLE
• Type of Device: ABIOMED BREETHE OXY-1 SYSTEM
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): BREETHE, INC.; 1500 joh ave; suite 190; halethorpe MD 21227
• Manufacturer Contact: ralph barisano ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 12530004
• MDR Text Key: 273318952
• Report Number: 1220648-2021-01051
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 008600017979301
• UDI-Public: (01)008600017979301(10)20210795(11)210617
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OXY-1 CONSOLE
• Device Catalogue Number: 001-3300-011
• Device Lot Number: 20210795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/27/2021
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1220648-12/17/2021-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic