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

Model Number OXY-1 CONSOLE

Device Problems Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

The console and pump used in this case was returned by the customer and a failure analysis investigation is underway.A supplemental mdr will be filed at the completion of the device's investigation.

Event Description

The complainant reported a (b)(6) white male with covid.The breethe ecmo system was selected for support and initiated.The console shut off, total time without support was 2-3 minutes, saturations dropped to the low 50s, and there was transient hypoxia.

Manufacturer Narrative

The device was evaluated and we feel the root cause of the reported complaint relates to the esd grounding configuration and/or component failure.The following corrections have been made: d(4): revised catalog, lot, and udi.H(6): removed 2993 from medical device problem code and add 1503 - pumping stopped.

• 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): ABIOMED, INC.; 22 cherry hill dr; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill dr; danvers, MA 01923
• MDR Report Key: 13003181
• MDR Text Key: 283694006
• Report Number: 1220648-2021-01191
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 860001797930
• UDI-Public: (01)860001797930(10)20210798(11)210713
• 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,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: 20210859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/22/2021
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White