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

Catalog Number 114364

Device Problems Fluid/Blood Leak (1250); Inadequate Ultra Filtration (1656)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Discomfort (2330); Diaphoresis (2452)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that at the end of a dialysis treatment with an ak 96 machine, an excessive fluid removal of 700ml were observed.The machine was set at 1.0, but it was actually off 1.7.The patient presented with sweating, fatigue, discomfort, and hypotension lowest blood pressure was 45/29mmhg).Saline was administered and the bp increased to 86/53mmhg.The "uf-cell was charged due to water leakage from the heat exchanger to the backup battery.After replacing the heat exchanger and disconnecting the backup battery, it returned to normal".No additional information is available.

Manufacturer Narrative

Initial reporter address: no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: device manufacture date: 2014 the device was inspected by local engineer.Technical evaluation of the ak 96 identified a water leakage from the heat exchanger.It is reported that water leakage also affected the backup battery.A leak from the heat exchangers cannot lead to excessive uf because these components are outside the mass balance and ultrafiltration portion of the ak 96 hydraulic circuit.The heat exchanger was replaced, and the backup battery was disconnected, no further issues were noted.The cause of the condition could not be determined however, the likely cause could be due to a wrong weight calculation or wrong uf setting.In addition, preventive maintenance of device was not performed in recent years.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 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: 16305139
• MDR Text Key: 308864096
• Report Number: 9616026-2023-00007
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female