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 Problem Hypothermia (1915)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

The console was not returned by the customer therefore a failure analysis investigation cannot be completed.If device is received after this date, an evaluation will be performed and a supplemental mdr will be filed.

Event Description

The complainant reported a (b)(6) male with coid recovered.The breethe ecmo system was selected for support and initiated.The patient's temperature fell to 32.1 degrees celsius and symptoms of hypothermic occurred for four (4) hours.A bair hugger and warming blankets was used to rewarm the patient.

• 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: 12977234
• MDR Text Key: 282561715
• Report Number: 1220648-2021-01182
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 8600017979301
• UDI-Public: (01)8600017979301(10)2021456368(11)201031
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: OXY-1 CONSOLE
• Device Lot Number: 20210857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/18/2021
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White