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

Catalog Number 955685

Device Problem Filling Problem (1233)

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

Event Date 01/21/2023

Event Type  malfunction  

Event Description

It was reported that during treatment with a prismaflex machine, the calcium syringe pump had a higher flow rate than programmed.The calcium levels increased (noted via laboratory testing) and therapy was discontinued.The event occurred during continuous renal replacement therapy (crrt) in which a 10% calcium gluconate solution is used and the machine is programmed with the same solution.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Initial reporter address - (b)(6).The device was not received for evaluation; however, it was inspected on-site by a baxter qualified technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The baxter technician checked prescription and prepared solutions and carried out an assessment the device.The technician also evaluated the external part of the machine, housing, display, connectors, hooks, pedestal, casters, power cord, scales, bubble detector ar, syringe holder, and the wrench pump handle.The technician checked the syringe clip setup, and everything was found to be within product specification ranges.Simulated therapy was performed for twenty-five minutes and was found to be functioning properly.The reported condition was not verified during functional testing.A review of the log file revealed that the prismaflex calcium delivery was set for a calcium concentration 223 mmol/l; while the reporter stated the concentration of the calcium solution, they used during the treatment was calcium gluconate with calcium concentration 680 mmol/l.Usual calcium gluconate solutions are in the range around 230 mmol/l, while solution concentrations in the range of 660-680 mmol/l are typical of the calcium chloride solutions.The reported condition was not verified during functional testing; however, there is a discrepancy between calcium concentration set and actual calcium concentration of the solution.This could potentially cause an over-delivery of ionic calcium to the patient¿s blood due to a user error.The prismaflex ifu requires (ref.Prismaflex operator manual, section 8.5.7, anticoagulation methods, safety system) that in case of citrate-calcium anticoagulation therapy a procedure of periodical advisory checkpoints shall be observed during the treatment.This advisory reminds an additional monitoring of patient¿s blood parameter through periodical blood chemical analysis in order to mitigate the risk of calcium over- or under-delivery.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 22643 ; SW 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16404932
• MDR Text Key: 310232759
• Report Number: 9616026-2023-00009
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414125547
• UDI-Public: (01)07332414125547
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2023

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: 955685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/20/2023
• 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: 10% CALCIUM GLUCONATE SOLUTION.