MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 96 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114362

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6) should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during use with an ak 96 machine, a reverse ultrafiltration issue occurred resulting in a weight gain estimated at 1.5kg.The patient¿s weight before dialysis was 72.3 kg, and the ultrafiltration was set to 3.2 kg.After one hour and 24 min of treatment the patient experienced chest tightness and shortness of breath.The treatment was discontinued, and the patient weight was 73.8 kg.No further information was available at the time of this report.

Manufacturer Narrative

Additional information added to h3, h6 and h10.H10: the device was not received for evaluation; however, the machine was evaluated on-site by a local non-baxter qualified technician.The parameters of the treatment and ultrafiltration (uf) were not reported.The alleged uf deviation was due to a temporary malfunction of the control uf module.An eddy current, caused by a short circuit from fiva electro valve and uf module short circuited due to a wet fiva valve, where the sealing cap was inexplicably missing.The electro valve was wet due to a leakage from a defective o-ring of the heater.The uf deviation was not duplicated by the technician through a simulated treatment.The of electrical current was not measured through a multimeter (one end of the multimeter connection was grounded and the other end was connected to the ultrafiltration housing).No alarm had been triggered during therapy to suggest an ultrafiltration event had occurred.Therefore, it is unlikely that the uf event actually occurred at all since the uf could not be 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.

• Brand Name: AK 96 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 SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18221678
• MDR Text Key: 329166369
• Report Number: 9616026-2023-00101
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/19/2024
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 72 KG