MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 98 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955607

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 11/28/2022

Event Type  malfunction  

Event Description

It was reported that during treatment with an ak 98 machine, the operator accidentally programmed the heparin delivery for a rate of 5 ml for hour, believing that the rate set was 5 u.I.Per hour.This led to an excessive heparin delivery to patient.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

The device was not received for evaluation; however, the event description clearly identify that the nurse set the heparin parameter believing that the unit of measurement was iu and not ml, causing an excessive heparin administration.Based on analysis of the ak98 operator's manual can be ascertained that the manual and the machine reports clearly that the measurement unit used to measure the heparin is ml and iu.There was no malfunction of the ak98 device and the machine worked according to specifications.The cause of the reported condition was associated with a use error when setting the heparin parameter.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: AK 98 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 - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16023117
• MDR Text Key: 308175302
• Report Number: 9616240-2022-00026
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201809
• 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
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• 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