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.

• Brand Name: AK 96
• 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 ; 2242702068
• 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
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 110655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/15/2021 Patient Sequence Number: 1