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

Catalog Number 955558

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Initial reporter city: (b)(6).H10: the device was received for evaluation.Per the reporter, the prismax control unit support treatments with systemic anticoagulation or regional citrate anticoagulation (rca) methods.During the reported treatment the regiocit citrate solution was used.For unknown reasons the user started the rca without an adequate check of the preset of the anticoagulation parameters.The prismax ifu provide multiple advice and warnings about the use of regional citrate anticoagu-lation therapy.The prismax operator¿s manual, section 1.1.2 - warnings, cautions and notes ¿ therapy - warns the user that ¿it is the hospital¿s responsibility to select treatment parameters.It is the responsibility of the physician to explicitly confirm these parameters are appropriate for each patient before treatment starts¿.The prismax operator¿s manual, section 6.5 - regional citrate anticoagulation ¿ advises the user to consult physician regarding regional citrate anticoagulation.Regional citrate anticoagulation can cause excessive citrate load and lead to metabolic alkalosis.The prismax operator¿s manual, section 6.6 - citrate management ¿ informs the user that the prismax system adapts to the clinic's requirements for regional citrate anticoagulation and that therapy sets the allowed concentration ranges.It¿s under responsibility of ¿an authorized user to set the clinic's choice of solutions in the system configuration¿.The prismax ifu requires periodical checks of the blood chemistry in order to prevent adverse impact of errors in setting of the rca parameters.In addition, the prismax control unit provides an automated anticoagulation checkpoint reminder which is a periodic reminder to check blood chemistry during rca.Therefore, the event has been deemed to be caused by user error.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the regional citrate anticoagulation was programmed incorrectly on a prismax machine during continuous renal replacement therapy.The machine was set aside with a note to confirm regiocit¿s programing prior to use on patients; however, the machine was mistakenly put back into service for use on a patient.The regiocit concentration was programmed at 10 mmol/l (vs 18 mmol/l) and calcium chloride at 80 mmol/l (vs 680 mmol/l).Nursing staff observed the error after therapy had begun.The machine was reprogrammed, and the machine was back to working order.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• 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; suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16974353
• MDR Text Key: 315715312
• Report Number: 3003504604-2023-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412630359
• UDI-Public: (01)00085412630359
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/24/2023
• Initial Date FDA Received: 05/22/2023
• 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: REGIOCIT.