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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION AK 96 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NameAK 96
Type of DeviceDIALYZER, 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 Key12177493
MDR Text Key264967765
Report Number9616026-2021-00033
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
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 Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number110655
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 Received07/27/2021
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
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