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

Catalog Number 110655

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter address.E1: initial reporter city.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient treated with dialysis using an ak 96 machine presented with a blood pressure drop (no numerical values), nausea, and vomiting during the treatment.The fluid removal was stopped, and 500 ml saline was administered.After receiving 500ml of normal saline through infusion, ultrafiltration was temporarily halted, and the patient's condition improved, along with an increase in blood pressure.The dialysis machine indicated dehydration of 1.8kg, and the patient weighed 2.5kg less after discontinuing the treatment.This suggests that the ultrafiltration setting on the machine was significantly different from the patient's actual ultrafiltration, with a discrepancy of at least 1200ml.A fluid leak from the bottom of the ak 96 machine was also observed which caused an excessive fluid removal of 1200 ml.No additional information is available.

Manufacturer Narrative

The device was not received for evaluation; however, a photograph was provided.Visual inspection of the photograph only showed the identification data and did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.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: 18813027
• MDR Text Key: 336620258
• Report Number: 9616026-2024-00012
• 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: 04/03/2024

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: 110655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/03/2024
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male