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

Catalog Number 955558

Device Problems Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported that a larger than expected amount of heparin was administered to a patient during tratment with a prismax machine.The nurse noticed the syringe lock was not fully closed.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).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not received for evaluation; however, based on the event description, is likely that when change syringe procedure was started, the user didn¿t lock the syringe plunger clip as required by the operator manual.After securing it properly, the same event did not happen again.An undisclosed clinical manoeuvre determined the pressure condition which caused an undesired heparin bolus being delivered to the patient.A negative filter pressure in conjunction with the unlocked syringe arm could lead to undesired delivery heparin.There was no malfunction of the prismax device.The cause of the reported condition was associated with a use error when attaching the heparin syringe incorrectly.The operator¿s manual of prismax (section connecting sets and fluids ¿ syringe) instructs the user that the ¿syringe installation is complete when the syringe test pass and the plunger clip is closed¿.In addition, the section - systemic anticoagulation ¿ requires that the user - when changing the syringe ¿ shall closing the plunger clip lock.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.

• 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; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15949098
• MDR Text Key: 308308357
• Report Number: 3003504604-2022-00035
• 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,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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
• Date Manufacturer Received: 01/09/2023
• 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: NI.