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

Catalog Number 110655

Device Problems Coagulation in Device or Device Ingredient (1096); Inadequate Ultra Filtration (1656)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359)

Event Date 01/15/2023

Event Type  Injury  

Event Description

It was reported a half an hour into treatment with an ak 96 machine, the dialyzer was noted that the blood had coagulated.The reporter noted the machine had an inaccurate ultrafiltration.The patient's blood pressure dropped "too fast".The dialyzer was replaced.The patient then felt uncomfortable and noted their blood pressure was 64/40mmhg.The doctor prescribed a reinfusion of normal saline, and the patient's blood pressure rose to 149/67mmhg.Treatment was discontinued.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the device was evaluated on site by a baxter qualified technician.The device underwent multimeter 287c and no leaks of electricity were noted.The diva, byva, tava, zeva and evva valve diaphragms and water level sensor underwent evaluation; due to ageing this likely led to leakage.The technician replaced all these components with new spare parts.After replacing with new spare parts, the technician calibrated the variable flow motor and the inside of the ultrafiltration unit, and the equipment passed the calibration without issue.The device underwent self-test and heat disinfection without any problems noted.A simulated treatment was then run for 1 hour and the machine ultrafiltered as per product specification.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to aging components.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: 16326569
• MDR Text Key: 309071337
• Report Number: 9616026-2023-00008
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

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?: No
• 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: 01/15/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/16/2023
• 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
• Treatment: UNSPECIFIED DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Weight: 72 KG