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 10/18/2021

Event Type  Injury  

Event Description

The complainant reported a (b)(6) female patient presenting as covid+ for ecmo support. During support, the patient endured a "clinically significant" episode of hypothermia with core temperature sinking to 35 degrees centigrade. Attempts to rewarm the patient were made via a bairhugger, however, to no avail. The patient was removed from the system and replaced with another ecmo unit with heating capabilities.

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.

• 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; baltimore MD 21227
• Manufacturer Contact: ralph barisano ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 12820024
• MDR Text Key: 280885524
• Report Number: 1220648-2021-01139
• Device Sequence Number: 1
• Product Code: DTZ
• 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

• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: OXY-1 CONSOLE
• Device Catalogue Number: 001-3300-011
• Device Lot Number: 20200352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/18/2021
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/16/2021 Patient Sequence Number: 1