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

Catalog Number 110655

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Loss of consciousness (2418)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that approximately half an hour before the end of treatment with an ak 96 machine, an unspecified "technical failure" alarm was triggered.It was reported that five minutes after the alarm, the patient lost consciousness.Treatment was stopped immediately.The patient was treated with about 200ml of normal saline and 20ml 50% glucose.The patient gradually regained consciousness, however, was experiencing sweating, dizziness, headache, nausea, vomiting and an increase in blood pressure reading.An additional 200 ml normal saline and 20 ml 50% glucose was administered and the patient¿s clinical condition improved.Nausea persisted.It was noted that the ultrafiltration had been set to 2.2l and the post treatment weight recording indicated that the patient had lost 2.9l.Another 400 ml normal saline and 20 ml 50% glucose was administered intra-venously as well as 300 ml hot water orally.The patient was monitored in the dialysis unit for three hours.It was reported that the patient declined hospitalization and was discharged to home.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation; therefore, a device analysis could not be completed.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
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12177493
• MDR Text Key: 264967765
• Report Number: 9616026-2021-00033
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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
• Initial Date Manufacturer Received: 06/20/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR