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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Discomfort (2330)
Event Date 09/08/2021
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 one hour into treatment with an ak96 control unit, a patient experienced chest tightness, increased in blood pressure and discomfort and the machine triggered an abnormal electrical conductance and the venous pressure high alarms. The machine was inspected and it showed that the dehydration was correct. The patient was treated with dexamethasone (5mg, intravenous bolus) and xintongding (10mg, orally). Thirty minutes later, the machine again triggered the same alarms and patient symptoms were not improved. Treatment was immediately stopped and heparin was used to "circulate the tube". The patient's weight was observed to have increased (inverse ultrafiltration). Exact weight measurement was not provided. Treatment was switched to another machine and the patient was put on oxygen (3l/min) and ecg monitoring. Symptoms was reported to have improved and treatment was completed. 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 Key12622680
MDR Text Key276100933
Report Number9616026-2021-00057
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 Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number110655
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Yes
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: 10/13/2021 Patient Sequence Number: 1
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