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

Catalog Number 955626

Device Problem Protective Measures Problem (3015)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: pediatric patient.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) with a prismax machine v.2, the preset fluid loss/gain limit of 150 changed by itself to 400g/3h.No excessive fluid removal was reported as it was only the set alarm limit that had changed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the event has been further evaluated and, as results, it has been concluded that the device malfunction do not have the likelihood to cause or contribute to death or serious injury.No excessive fluid removal was reported as only the set alarm limit that had changed.This issue only occurs when the operator enters a non-default value for the gain/loss limit setting during the initial setup, a filter change is made, and then the operator enters a change to the patient weight and/or hematocrit, in which case the gain/loss limit reverts to the default value.The prismax system monitors the patient fluid removed to protect the patient from fluid imbalance.Additional information is reported on the history screen including the unintended patient fluid gain, expressed as the accumulated fluid balance error within the last three hours.If the patient fluid removed is higher than the target value, there is an alarm for unintended fluid loss.If the patient fluid removed is lower than the target value, there is an alarm for unintended fluid gain.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Functional testing was performed, and service engineer was unable to duplicate the reported malfunction.A device history review revealed no issues that could have caused or contributed to the reported issue.Reviews of log files of previous similar events had shown that the reported condition occurs when the operator chooses to load the initial prescription settings from a profile, rather than enter each setting manually.After the treatment was started, at least one prescription setting change was made.The operator chose to end the treatment and use the same patient button to change to a new filter set (a filter set change must be done when the maximum treatment time for a filter has been reached).In addition, at least one prescription setting change was made after treatment was started again with the new filter set.In these conditions, the unintended change of the gain/loss limit occurred.The investigation concluded that the software was using the profile values outside the scope of setup (i.E.During treatment).Therefore, the cause of the prescription settings appearing to change without any direct manual entry is the software loading values from the profile, for display in the change dialog, rather than loading the current settings.Therefore, the root cause of this unintended behavior was that the design input was incompletely implemented.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX CONTROL UNIT
• 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: 13121572
• MDR Text Key: 287031340
• Report Number: 3003504604-2021-00010
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

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: 955626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/31/2022; 02/21/2022
• Supplement Dates FDA Received: 02/01/2022; 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1