MAUDE Adverse Event Report: ABIOMED, INC. OXY-1 PLU DISPOSABLE KIT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number OXY-1 PLU DISPOSABLE KIT

Device Problem Pumping Stopped (1503)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/19/2021

Event Type  Injury  

Event Description

The complainant reported a (b)(6) male patient presenting with acute myocardial infarction and cardiogenic shock for breethe ecmo support.During use of the device, stoppage of flow occurred that required hand cranking of the device to sustain the patient's support.The patient's mean arterial pressure dropped to the "low 50's" during this time.The pump driver was suspected as problematic, therefore, was switched out (along with a new pump) and flow was restored.

Manufacturer Narrative

The device was not received for investigation.If any new information is obtained, a supplemental report will be filed.

Manufacturer Narrative

Data logs as well as an image of the device's cannula was provided.Discussions with the facility noted that a high volume of blood traveling down the graft which led to a backup of venous blood in the arm.The patient was also noted to have been without heparin for "several hours" prior to the incident.Analysis of the provided image revealed clot throughout the cannula.Data logs noted several instances of rapid reduction of blood flow and subsequent recovery during use.As such, we believe the root cause of the reported issue was related to ingested biomaterial.The following revisions have been made for section d: brand name, common device name, model number, catalog number, serial number, expiration date, and unique identifier (udi) number.The following revisions have been made for section h: device manufacture date.

• Brand Name: OXY-1 PLU DISPOSABLE KIT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 13026422
• MDR Text Key: 282559259
• Report Number: 1220648-2021-01204
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: OXY-1 PLU DISPOSABLE KIT
• Device Catalogue Number: 1000140
• Device Lot Number: 20210861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/19/2021
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White