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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 114362
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2021
Event Type  malfunction  
Event Description
It was reported during setup with an ak 96 machine. A water leakage was noted. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
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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 Key13228160
MDR Text Key289677494
Report Number9616026-2022-00001
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
Type of Report Initial,Followup
Report Date 02/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114362
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/11/2022 Patient Sequence Number: 1
Treatment
NA.
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