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

Catalog Number 955558

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

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the prismax machine was programmed wrong and two (2) patients received the wrong dose of calcium gluconate.During troubleshooting with a baxter representative, the peritoneal dialysis nurse (pdn) noted both patient¿s calcium compensation was at 200%.As the prismax does not allow more than 200% of calcium compensation, the baxter representative asked the pdn to investigate the calcium concentration that was configured on the machine in comparison to the calcium concentration the patient was receiving via the syringe.Upon investigation, the pdn found the prismax 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.

Manufacturer Narrative

D4: serial no: the reported potential serial numbers: (b)(6).H10: the device was not received for evaluation; however, the machine was evaluated on-site by a baxter employee.Upon the initial prismax machine set up in the facility, the baxter technician set the calcium configuration to the default setting of calcium chloride which was signed off by the medical center¿s staff nurse.On the day of the event, the peritoneal dialysis nurse did not review the calcium configuration prior to the start of therapy, which caused the patient to receive an incorrect dose of calcium gluconate.The cause of the condition was due to a user error.Use errors and proper user instructions are addressed in the prismax 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.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 ste 170; brooklyn park MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17568112
• MDR Text Key: 321824598
• Report Number: 3003504604-2023-00019
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• 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
• Date Manufacturer Received: 09/21/2023
• 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