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

Catalog Number 955606

Device Problems Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 10/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient experienced an air embolism when performing a fast recovery with the main switch on an ak 98 machine while performing therapy at home.The machine generated several alarms (of unknown type) during the treatment, including ¿air in the venous drip chamber alarm¿.The patient tried to perform a manual blood return for an unknown reason and because the venous line was clamped, the patient shut down the machine at the main switch at the back.By the time the machine recovered (a few seconds), the venous clamp opened and due to a high venous pressure, the air in the circuit entered directly to the patient.The patient was transferred to a hospital for hyperbaric chamber treatment.At the time of this report, the patient has recovered.No additional information is available.

Manufacturer Narrative

H10: the device was evaluated on site by a qualified technician and found working as per specifications.Based on log file analysis, the reported condition was not verified.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.

Manufacturer Narrative

Based on additional information received, the ak98 machine was determined not to be a factor in the reported adverse 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: 15841183
• MDR Text Key: 304096906
• Report Number: 9616240-2022-00023
• Device Sequence Number: 1
• Product Code: KDI
• 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,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 955606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male