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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 114364
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Diaphoresis (2452); Confusion/ Disorientation (2553)
Event Date 10/20/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter address: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that 1. 5 hours after starting treatment with an ak 96 machine, the patient developed sweating, nausea, confusion and blood pressure was 81/60 mmhg. The ultrafiltration was stopped, however symptoms recurred 2 hours after dialysis and the patient was treated with fluid replacement and hemodialysis was stopped. During the patient dialysis, the interface buckle between the water outlet tubing of the substitution solution and the internal connection of the machine got loose, resulting in the possibility of a fluid leak. No alarm condition was reported in connection with the treatment. 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 Key12909394
MDR Text Key281528567
Report Number9616026-2021-00072
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
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 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114364
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
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 Treatment Data
Date Received: 12/01/2021 Patient Sequence Number: 1
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