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

Catalog Number 107640

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

Facility name: (b)(6).Phone number: (b)(6).Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization eua200704 to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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 user interrupted the priming phase at 15:11:28 without 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.

• Brand Name: PRISMAFLEX SETS ST
• 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 - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15053563
• MDR Text Key: 296151583
• Report Number: 8010182-2022-00208
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414075651
• UDI-Public: (01)07332414075651
• 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
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 107640
• Device Lot Number: 22B0082CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRISMAX MACHINE
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Male