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

Catalog Number 114870

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Type  malfunction  

Event Description

It was reported a prismaflex machine was programmed wrong and an unspecified quantity of patients received the wrong dose of calcium gluconate.The nurse noted the calcium compensation was at 200%; however, the prismaflex does not allow more than 200% of calcium compensation.Upon a later investigation, the pdn found the prismaflex machine was configured as calcium chloride and not calcium gluconate.The hospital¿s protocol is for calcium gluconate which is what was in the syringe.The hospital has since amended all their machines to reflect calcium gluconate.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was not received for evaluation; however, the machine was evaluated on-site by a baxter employee.Upon the initial prismaflex machine set up in the facility, the machine was configurated to infuse both calcium chloride and calcium gluconate.On the day of the event however, the clinical user did not review the calcium configuration prior to the start of therapy and selected the setting ¿calcium chloride¿ even though the syringe had been filled with calcium gluconate solution.This caused an under delivery of calcium.Therefore, the cause of the condition was due to a user error.Use errors and proper user instructions are addressed in the prismaflex operators manual which is included with every machine upon set up.The manual warns the user to ¿view and confirm the prescription before connecting the patient and starting treatment¿.The medical staff was retrained to verify the calcium configuration prior to the start of therapy and the hospital has since amended all their machines to reflect calcium gluconate which is the hospital¿s protocol.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17573303
• MDR Text Key: 321473987
• Report Number: 9616026-2023-00052
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2023
• 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: CALCIUM GLUCONATE