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

Model Number OXY-1 CONSOLE

Device Problems Pumping Stopped (1503); Failure to Deliver (2338)

Patient Problem Respiratory Failure (2484)

Event Date 03/08/2021

Event Type  Death  

Manufacturer Narrative

The investigation is on-going at this time.Upon completion of the investigation a final report will be filed.

Event 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.

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.

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.

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
• Type of Device: 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
• MDR Text Key: 243652940
• Report Number: 1220648-2021-00816
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00860001797930
• UDI-Public: (01)00860001797930(11)201104
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• 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: 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
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Death
• Patient Age: 37 YR
• Patient Sex: Male