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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION AK 96 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114362
Device Problem Filtration Problem (2941)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2023
Event Type  malfunction  
Event Description
It was reported an excessive ultrafiltration event occurred on an ak 96 machine.After four hours of hemodialysis therapy, the expected ultrafiltration volume was 3100ml; however, the actual ultrafiltration volume was 3700ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional information added to h3, h6 and h10.H10: the device was not received for evaluation; however, the device was evaluated on site by a non-baxter technician.The technician did not provide any information of their device evaluation; therefore, the reported condition could not be verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
AK 96 MACHINES
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 60073
2242702068
MDR Report Key17613470
MDR Text Key321871633
Report Number9616026-2023-00060
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414111984
UDI-Public(01)07332414111984
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 Nurse
Type of Report Initial,Followup
Report Date 09/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number114362
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/28/2023
Initial Date FDA Received08/24/2023
Supplement Dates Manufacturer Received09/04/2023
Supplement Dates FDA Received09/28/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age49 YR
Patient SexMale
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