MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955558

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Bradycardia (1751)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

The device was inspected on site by a qualified technician.The air detector was checked for functionality during treatment simulation.No air detection during this treatment was observed.However, the blood pump was observed to have stopped for more than 10 minutes which prevented the return of blood to the patient.A device history review revealed no issues that could have caused or contributed to the reported issue.The lox files were reviewed and treatment ran for approximately one and a half hours.One hour after the start of treatment, the user pressed "end" , pausing the pumps and losing the clamp, however, they did not navigate the "end" mode.After the blood pump was stopped for ten minutes, a t0948 alarm was correctly generated, forcing the user to end treatment.There is no evidence of air or foam present in the system at any point in the therapy.The machine functioned as intended and did not cause the reported event.The cause of the event could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after one hour of continuous renal replacement therapy with a prismax machine and a prismaflex st150 set, the prismax machine, had an unspecified issue detecting air bubbles.The nurse stopped the blood pump for approximately 10 minutes.During this time, the user tried to have a better function of the catheter (access line), reported as ¿aspiration through the red line was difficult¿.Eventually the treatment was ended without the extracorporeal blood return.Approximately 15-30 minutes after the treatment was ended, the patient became bradycardic and experienced an air embolism, specified as "bubbles were seen in the right heart chambers".The patient was intubated and was treated with ephedrine 30mg, adrenaline 0.5mg and an emergency hyperbaric chamber session was performed.On the following day, the patient was extubated and was administered oxygen at a low flow of 2l / min maximum.No additional information is available.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 11802703
• MDR Text Key: 249975483
• Report Number: 1416980-2021-02792
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/10/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention