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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 Infusion or Flow Problem (2964)
Patient Problems High Blood Pressure/ Hypertension (1908); Swelling/ Edema (4577)
Event Date 06/03/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that, during treatment with hemodialysis machine ak 96, air and water leakage occurred at the elbow on negative pressure pump. After 3 hours and 40 minutes of dialysis treatment, the patient felt swelling and discomfort of the upper limbs and face. The treatment was stopped. The accumulated ultrafiltration volume displayed by the ak 96 showed 2. 19l. Post treatment weight recording was (b)(6) kg indicating that the patient had gained 3. 7l compared to the pre treatment weight and their blood pressure had increased to 183/90 mmhg. No alarm was generated during the treatment. A new 4 hour treatment was initiated, using a different ak 96 dialysis machine and the patient reportedly had no discomfort. 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 Key12224734
MDR Text Key263392970
Report Number9616026-2021-00036
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 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114364
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 Received08/09/2021
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: 07/26/2021 Patient Sequence Number: 1
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