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

Catalog Number 955558

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 06/09/2022

Event Type  Death  

Event Description

It was reported that during continuous renal replacement therapy (crrt) therapy on a patient experiencing multiorgan failure and septic shock on a prismax machine and a prismaflex set, the patient desaturated and was cyanotic despite being put on fio2 100%.The patient went into cardiac arrest and cardiopulmonary resuscitation efforts were unsuccessful.The patient subsequently passed away.The cause of death was reported to be due to massive air embolism as air was observed in the tubing at the time of disconnection of the patient at the end of the incident.Analysis of the log files indicates a user error where the user connected the patient was connected to both access and return end of the set to the patient 's vascular access during the priming phase.The priming was not completed, however, the user started the treatment without entering the patient connection phase, resulting in the reported air from the unprimed set getting into the patient's blood circuit and leading to the reported cause of death of air embolism.No additional information is available.

Manufacturer Narrative

(b)(6).A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The service technician evaluated the device on site.The evaluation included the functionality of the scales, of the pressure sensors and of the air bubble detector and were found to be performing within specification limits.A successful simulated treatment was performed.The event history log showed the priming phase was started at 14:53:40.The machine alarmed t0781 ¿ extreme filter pressure at 14:59:27 and later, two other times.This alarm stops all machine pumps and pauses priming.However, the user resumed the priming.After 19 minutes of the priming phase, the machine generated other pressure alarms which caused the stop of the priming.The user again resumed the priming.The analysis of the pressure reading at this point showed a sudden rise of the filter pressure which exceeded 450 mmhg.The return pressure showed similar and simultaneous peaks.The user interrupted the priming phase at 15:11:28 without the device entering the patient connection phase.Analysis of the log files indicates a user error where the user connected the patient was connected to both access and return end of the set to the patient 's vascular access during the priming phase.The priming was not completed, however, the user started the treatment without entering the patient connection phase, resulting in the reported air from the unprimed set getting into the patient's blood circuit and leading to the reported cause of death of air embolism.The operator manual of the prismax instructs the user that before the patient connection a 7 steps procedure shall be carried out.The 6th step is priming of the set and the user is instructed to follow the user interface instructions presented on the to prepare for priming the set.In detail the user is required to connect the access line and the return line to the priming bag through the y-connector specifically provided with the filter set.The operator¿s manual describes that the ¿priming flushes disposable set lines with sterile fluid and checks for line occlusions.The operator manual additionally instructs the user that the air detection function is disabled during priming.However, during the end of the priming, the system will perform a check if air is present in the return line.Make sure there is no air between the air bubble detector (abd) and the patient end of the return line before connecting to the patient.If air is present, manual prime can be used to remove air, or use the reprime option if a large amount of air needs to be removed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10:the device was inspected on site by a service technician.The evaluation included the functionality of the scales of the pressure sensors and of the air bubble detector and a simulated treatment was also performed.No malfunctions were detected.Based on the available information and analysis of the lox files, the cause of the reported death is associated with a user error during the priming phase.There is no reasonable evidence to suggest that there was any malfunction or defect involving the prismax machine that could have cause or contributed to the reported event.The clinician started the setup of the treatment, then the operations were interrupted for about two hours.The priming phase was started without connecting the patient lines to the priming bag and the clinician did not check to see that the patient was not connected to the machine as requested by the prismax operator 's manual and by the labelling of the user interface of the machine.The priming phase was started with the patient lines connected to the patient causing the air in the line to enter the patient¿s blood circuit leading to the reported an air embolism and subsequent death.The prismax operator's manual, table 2-1: "steps for selecting the treatment, connecting sets and fluids, and priming and connecting patient" instructs the user to follow 7 steps before the patient connection.The graphic user interface (gui) of the prismax machine provides detailed instructions for the correct procedure of setup of the extracorporeal circuit and preparation of the priming.Before starting the bag loading, the graphic user interface (gui) instructs the user to hang the priming bag on the left side of the prismax.Machine and to connect the access patient line and the effluent line to the priming bag through the y-connector provided with the filter set.Then, the user is instructed to check that no line is connected to the patient before starting the priming.According to the prismax operator's manual, 2.3 " priming and connecting the patient ", ¿priming flushes disposable set lines with sterile fluid and checks for line occlusions.Priming the set requires at least one priming cycle, and each priming cycle uses at least one 1 l priming solution bag.The number and type of priming cycles and the time required to complete a prime depends on the set in use¿.Caution!: "air detection is disabled during priming.However, during the end of the priming, the system will perform a check if air is present in the return line.Make sure there is no air between the air bubble detector (abd) and the patient end of the return line before connecting to the patient.If air is present, manual prime can be used to remove air, or use the reprime or flush options if a large amount of air needs to be removed." should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• 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: 15065435
• MDR Text Key: 296229263
• Report Number: 3003504604-2022-00020
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412630359
• UDI-Public: (01)00085412630359
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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?: 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: 06/20/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: PRISMAFLEX SETS ST.
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Male