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

Model Number	OXY-1 CONSOLE
Medical Device Problem Codes	Pumping Stopped (1503); Failure to Deliver (2338)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	03/08/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is on-going at this time.Upon completion of the investigation a final report will be filed.
Event or Problem Description
A patient was transferred to the tertiary medical center with a covid + diagnosis and in need of intubation and escalated medical care.An oxy-1 ecmo device was placed for support and oxygenation.The system provided v-v cannulation for 15 days.During the support, on day 11, there were calls made for technical support when the screen was noted to be darkened, due the power being mistakenly shut off due to a user error.That power failure was rectified and support proceeded on the same oxy-1 system.On day 15 the oxy-1 ecmo had what was termed a system failure.The staff was then forced to provide emergency resuscitation, which failed.The patient expired.
Additional Manufacturer Narrative
The investigation into the event has concluded.The oxy-1 product was tested and a root cause was unable to be determined.Team is unable to determine the cause of the system failure.The failure will be monitored and trended.
Additional Manufacturer Narrative
Since previous reports filed the manufacturer has updated udi information and product return to manufacturer documentation.This is the final supplemental correction report.
Additional Manufacturer Narrative
The following data has been corrected: 1) d4 - update catalog # 001-3300-011, 2) h- update medical device problem code to 1503 - pumping stopped, 3) h- update component code ¿ with 765 - controller, 4) type of reportable event changed from serious injury to death (last supplemental erroneously had serious injury, while initial report showed death).

• Brand Name: OXY-1 SYSTEM
• Common Device Name: 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: 11610688
• Report Number: 1220648-2021-00816
• Device Sequence Number: 3086137
• Product Code: DTZ
• UDI-Device Identifier: 00860001797930
• UDI-Public: (01)00860001797930(11)201104
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K200109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2022

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?: Yes
• Operator of Device: 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: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/08/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021; 03/08/2021; 03/08/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/11/2021; 09/22/2021; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Death
• Patient Age: 37 YR
• Patient Sex: Male